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A Safety and Efficacy Study of the Hepatitis E Vaccine in Nepal.

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ClinicalTrials.gov Identifier: NCT00287469
Recruitment Status : Completed
First Posted : February 6, 2006
Results First Posted : May 29, 2019
Last Update Posted : May 29, 2019
Sponsor:
Collaborators:
GlaxoSmithKline
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
U.S. Army Medical Research and Development Command

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Hepatitis
Interventions Biological: Hepatitis E vaccine, recombinant (Sar 56 kDa)
Other: Placebo
Enrollment 2000
Recruitment Details 2000 subject were recruited by Royal Nepalese Army investigators at the Shree Birendra Hospital, Kathmandu from a well characterized population of Royal Nepalese Army military personnel stationed in the Kathmandu Valley and their family members and up to 5 US citizens residing in the Nepal.
Pre-assignment Details  
Arm/Group Title Placebo 20mcg Recombinant HEV
Hide Arm/Group Description

PBS buffer placebo containing alum was administered intramuscularly in the deltoid according to a 0, 1 and 6 month schedule.

Placebo: PBS buffer placebo containing alum

20mcg of recombinant HEV antigen administered intramuscularly in the deltoid according to a 0, 1 and 6 month schedule

Hepatitis E vaccine, recombinant (Sar 56 kDa): 20mcg or rhE Sar 56 kDa/dose of 0.5 mL, aluminium hydroxide (0.5 mg/dose) and phenoxyethanol (2.5 mg/dose)

Period Title: Overall Study
Started 1000 1000
Completed 780 786
Not Completed 220 214
Reason Not Completed
serious adverse event             1             6
Adverse Event             1             1
moved from area             144             138
Lost to Follow-up             74             69
Arm/Group Title Placebo 20mcg Recombinant HEV Total
Hide Arm/Group Description

PBS buffer placebo containing alum was administered intramuscularly in the deltoid according to a 0, 1 and 6 month schedule.

Placebo: PBS buffer placebo containing alum

20mcg of recombinant HEV antigen administered intramuscularly in the deltoid according to a 0, 1 and 6 month schedule

Hepatitis E vaccine, recombinant (Sar 56 kDa): 20mcg or rhE Sar 56 kDa/dose of 0.5 mL, aluminium hydroxide (0.5 mg/dose) and phenoxyethanol (2.5 mg/dose)

Total of all reporting groups
Overall Number of Baseline Participants 1000 1000 2000
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Female Number Analyzed 4 participants 4 participants 8 participants
31.3  (12.69) 28.0  (8.29) 29.6  (10.07)
Male Number Analyzed 996 participants 996 participants 1992 participants
25.1  (6.12) 25.2  (6.34) 25.2  (6.23)
[1]
Measure Analysis Population Description: Male and Female participants add up to the total number for each group: Placebo (1000) and 20mcg Recombinant HEV (1000).
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1000 participants 1000 participants 2000 participants
Female
4
   0.4%
4
   0.4%
8
   0.4%
Male
996
  99.6%
996
  99.6%
1992
  99.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Nepal Number Analyzed 1000 participants 1000 participants 2000 participants
1000 1000 2000
1.Primary Outcome
Title Percent of Participants of Definite Hepatitis E by Category and Immunological Markers (Anti HEV) During the Follow-up Period
Hide Description

Percent of participants of definite hepatitis E by category and immunological markers (anti HEV) during the follow-up period.

  • Illness for at least 3 days comprised of at least 3 of the following symptoms: fatigue, loss of appetite, abdominal discomfort, right upper quadrant pain, nausea, vomiting
  • Peak of Alanine Aminotransferase (ALT) greater then 2.5 times the upper limit of normal (2.5 x 42 =105)
  • Percent of Participants = n x 100 / N
Time Frame 14 days after dose 3 at 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 20mcg Recombinant HEV Placebo
Hide Arm/Group Description:

20mcg of recombinant HEV antigen administered intramuscularly in the deltoid according to a 0, 1 and 6 month schedule

Hepatitis E vaccine, recombinant (Sar 56 kDa): 20mcg or rhE Sar 56 kDa/dose of 0.5 mL, aluminium hydroxide (0.5 mg/dose) and phenoxyethanol (2.5 mg/dose)

PBS buffer placebo containing alum was administered intramuscularly in the deltoid according to a 0, 1 and 6 month schedule.

Placebo: PBS buffer placebo containing alum

Overall Number of Participants Analyzed 1000 1000
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percent of Participants
Jaundice; IgM ≥ 100 WR U/mL
0.0
(0.0 to 0.4)
6.9
(5.3 to 8.8)
Jaundice; total lg ≥ 2500 WR U/mL
0.3
(0.1 to 1.0)
0.1
(0.0 to 0.6)
Jaundice; IgM≥100 WR U/mL or total lg≥2500 WR U/mL
0.3
(0.1 to 1.0)
7.0
(5.4 to 8.9)
Illness; IgM ≥ 100 WR U/mL
0.0
(0.0 to 0.4)
0.3
(0.1 to 1.0)
Illness; total lg ≥ 2500 WR U/mL
0.0
(0.0 to 0.4)
0.0
(0.0 to 0.4)
Illness; IgM≥100 WR U/mL or total lg≥2500 WR U/mL
0.0
(0.0 to 0.4)
0.3
(0.1 to 1.0)
Jaun/Ill; IgM≥100 WR U/mL or total lg≥2500 WR U/mL
0.3
(0.1 to 1.0)
7.4
(5.7 to 9.3)
2.Secondary Outcome
Title Percent of Participants of Definite Hepatitis E Disease by Category During the Follow-up Period
Hide Description

Percent of participants of definite hepatitis E and vaccine efficacy by category during the follow-up period

  • Illness for at least 3 days comprised of at least 3 of the following symptoms: fatigue, loss of appetite, abdominal discomfort, right upper quadrant pain, nausea, vomiting
  • Peak of Alanine Aminotransferase (ALT) greater then 2.5 times the upper limit of normal (2.5 x 42 =105)
  • Percent of participants = n x 100 / N
Time Frame 14 days after dose 2 until 14 days after dose 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 20mcg Recombinant HEV Placebo
Hide Arm/Group Description:

20mcg of recombinant HEV antigen administered intramuscularly in the deltoid according to a 0, 1 and 6 month schedule

Hepatitis E vaccine, recombinant (Sar 56 kDa): 20mcg or rhE Sar 56 kDa/dose of 0.5 mL, aluminium hydroxide (0.5 mg/dose) and phenoxyethanol (2.5 mg/dose)

PBS buffer placebo containing alum was administered intramuscularly in the deltoid according to a 0, 1 and 6 month schedule.

Placebo: PBS buffer placebo containing alum

Overall Number of Participants Analyzed 1000 1000
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percent of Participants
Jaundice; IgM ≥ 100 WR U/ml
0.1
(0.0 to 0.6)
0.8
(0.4 to 1.6)
Jaundice; total Ig ≥ 2500 WR U/ml
0.0
(0.0 to 0.4)
0.0
(0.0 to 0.4)
Jaundice; IgM≥100 WR U/mL or total lg≥2500 WR U/mL
0.1
(0.0 to 0.6)
0.8
(0.4 to 1.6)
Illness; ImG ≥ 100 WR U/ml
0.0
(0.0 to 0.4)
0.0
(0.0 to 0.4)
Illness; total Ig ≥ 2500 WR U/ml
0.0
(0.0 to 0.4)
0.0
(0.0 to 0.4)
Jaun/Ill; IgM≥100 WR U/mL or total lg≥2500 WR U/mL
0.1
(0.0 to 0.6)
0.8
(0.4 to 1.6)
3.Secondary Outcome
Title Number of Suspected, Definite, Probable and Not Confirmed Hepatitis E Disease Cases
Hide Description Number of suspected, definite, probable and not confirmed hepatitis E disease cases during surveillance period
Time Frame before dose 1 thru 14 days after dose 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo 20mcg Recombinant HEV
Hide Arm/Group Description:

PBS buffer placebo containing alum was administered intramuscularly in the deltoid according to a 0, 1 and 6 month schedule.

Placebo: PBS buffer placebo containing alum

20mcg of recombinant HEV antigen administered intramuscularly in the deltoid according to a 0, 1 and 6 month schedule

Hepatitis E vaccine, recombinant (Sar 56 kDa): 20mcg or rhE Sar 56 kDa/dose of 0.5 mL, aluminium hydroxide (0.5 mg/dose) and phenoxyethanol (2.5 mg/dose)

Overall Number of Participants Analyzed 1000 1000
Measure Type: Number
Unit of Measure: Number of Hepatitis E Cases
Any acute hep cases: before dose 1 0 1
Any hep cases: within 14 days after dose 1 1 3
Any hep cases: between 14 days after dose 1 and 2 5 2
Any hep cases: within 14 days after dose 2 0 0
Any hep cases: between 14 days after dose 2 and 3 7 4
Any hep cases: within 14 days after dose 3 1 0
Any hep cases: from 14 days after dose 3 78 9
Any hep cases: Total 92 19
Definite hepE cases: before dose 1 0 0
Definite hepE cases: within 14 days after dose 1 1 3
Definite hepE cases: btwn 14dys after dose 1 and 2 3 2
Definite hepE cases: within 14 days after dose 2 0 0
Definite hepE cases: btwn 14dys after dose 2 and 3 7 1
Definite hepE cases: within 14 days after dose 3 1 0
Definite hepE cases: from 14 days after dose 3 66 3
Definate hepE cases: Total 78 9
Probable hepE cases 0 0
Not confirmed hepE: before dose 1 0 1
Not confirmed hepE: within 14 days after dose 1 0 0
Not confirmed hepE: btwn 14dys after dose 1 and 2 2 0
Not confirmed hepE: within 14 days after dose 2 0 0
Not confirmed hepE: btwn 14dys after dose 2 and 3 0 3
Not confirmed hepE: within 14 days after dose 3 0 0
Not confirmed hepE: from 14 days after dose 3 12 6
Not confirmed hepE: total 14 10
Time Frame Within 31 days (days 0-30) post-vaccination
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo 20mcg Recombinant HEV
Hide Arm/Group Description

PBS buffer placebo containing alum was administered intramuscularly in the deltoid according to a 0, 1 and 6 month schedule.

Placebo: PBS buffer placebo containing alum

20mcg of recombinant HEV antigen administered intramuscularly in the deltoid according to a 0, 1 and 6 month schedule

Hepatitis E vaccine, recombinant (Sar 56 kDa): 20mcg or rhE Sar 56 kDa/dose of 0.5 mL, aluminium hydroxide (0.5 mg/dose) and phenoxyethanol (2.5 mg/dose)

All-Cause Mortality
Placebo 20mcg Recombinant HEV
Affected / at Risk (%) Affected / at Risk (%)
Total   1/1000 (0.10%)      6/1000 (0.60%)    
Hide Serious Adverse Events
Placebo 20mcg Recombinant HEV
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   200/1000 (20.00%)      143/1000 (14.30%)    
Blood and lymphatic system disorders     
Eosinophilia * 1  0/1000 (0.00%)  0 3/1000 (0.30%)  3
Cardiac disorders     
Myocardial infarction * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Pericarditis * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Congenital, familial and genetic disorders     
Gilbert's syndrome * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Hydrocele * 1  1/1000 (0.10%)  1 1/1000 (0.10%)  1
Ear and labyrinth disorders     
Deafness * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Eye disorders     
Blindness * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Conjunctivitis * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Corneal ulcer * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Gastrointestinal disorders     
Abdominal hernia * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Abdominal pain * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Anal fissure * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Aphthous stomatitis * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Diarrhoea * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Dyspepsia * 1  4/1000 (0.40%)  4 1/1000 (0.10%)  1
Enteritis * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Food poisoning * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Gastritis * 1  1/1000 (0.10%)  1 3/1000 (0.30%)  3
Haemorrhoids * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Inguinal hernia * 1  2/1000 (0.20%)  2 1/1000 (0.10%)  1
General disorders     
Accidental death * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Carcadian rhythm sleep disorder * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Death * 1  0/1000 (0.00%)  0 5/1000 (0.50%)  5
Gravitational oedema * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Pyrexia * 1  6/1000 (0.60%)  6 1/1000 (0.10%)  1
Hepatobiliary disorders     
Alcoholic liver disease * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Cholelithiasis * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Hepatic cirrhosis * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Hepatomegal * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Hyperbilirubinaemia * 1  2/1000 (0.20%)  2 1/1000 (0.10%)  1
Jaundice * 1  2/1000 (0.20%)  2 2/1000 (0.20%)  2
Jaundice hepatocellular * 1  5/1000 (0.50%)  5 2/1000 (0.20%)  2
Infections and infestations     
Abscess limb * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Acute tonsillitis * 1  2/1000 (0.20%)  2 0/1000 (0.00%)  0
Amoebiasis * 1  3/1000 (0.30%)  3 1/1000 (0.10%)  1
Appendicitis * 1  4/1000 (0.40%)  4 3/1000 (0.30%)  3
Ascariass * 1  1/1000 (0.10%)  1 2/1000 (0.20%)  2
Cellulitis * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Cestode infection * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Dermatitis infection * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Diarrhoea infectious * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Dysentery * 1  3/1000 (0.30%)  3 1/1000 (0.10%)  1
Encephalitis japanese b * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Gastroenteritis * 1  2/1000 (0.20%)  2 2/1000 (0.20%)  2
Giardiasis * 1  3/1000 (0.30%)  3 6/1000 (0.60%)  6
Hepatitis E * 1  81/1000 (8.10%)  81 10/1000 (1.00%)  10
Herpes zoster * 1  1/1000 (0.10%)  1 1/1000 (0.10%)  1
Hookworm infection * 1  4/1000 (0.40%)  4 3/1000 (0.30%)  3
Hymenolepiasis * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Labyrinthitis * 1  3/1000 (0.30%)  3 1/1000 (0.10%)  1
Leptospirosis * 1  12/1000 (1.20%)  12 2/1000 (0.20%)  2
Lower respiratory tract infection * 1  2/1000 (0.20%)  2 0/1000 (0.00%)  0
Malaria * 1  3/1000 (0.30%)  3 1/1000 (0.10%)  1
Measles * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Meningitis viral * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Mumps * 1  2/1000 (0.20%)  2 1/1000 (0.10%)  1
Neurocysticercosis * 1  1/1000 (0.10%)  1 1/1000 (0.10%)  1
Orchitis * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Otitis media chronic * 1  0/1000 (0.00%)  0 2/1000 (0.20%)  2
Paratyphoid fever * 1  7/1000 (0.70%)  7 8/1000 (0.80%)  8
Pharyngitis * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Pneumonia * 1  2/1000 (0.20%)  2 0/1000 (0.00%)  0
Pulmonary tuberculosis * 1  3/1000 (0.30%)  3 0/1000 (0.00%)  0
Respiratory tuberculosis * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Salmonella bacteraemia * 1  3/1000 (0.30%)  3 7/1000 (0.70%)  7
Scrub typhus * 1  3/1000 (0.30%)  3 0/1000 (0.00%)  0
Sexually transmitted disease * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Tinea pedis * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Tonsilitis * 1  3/1000 (0.30%)  3 1/1000 (0.10%)  1
Tuberculosis * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Tuberculous pleurisy * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Typhoid fever * 1  24/1000 (2.40%)  24 30/1000 (3.00%)  30
Upper respiratory tract infection * 1  4/1000 (0.40%)  4 6/1000 (0.60%)  6
Urinary tract infection * 1  1/1000 (0.10%)  1 2/1000 (0.20%)  2
Viral infection * 1  9/1000 (0.90%)  9 5/1000 (0.50%)  5
Wound infection * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Injury, poisoning and procedural complications     
Abdominal injury * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Alcohol poisoning * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Ankle fracture * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Blast injury * 1  0/1000 (0.00%)  0 3/1000 (0.30%)  3
Eye injury * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Face injury * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Facial bones fracture * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Femur fracture * 1  2/1000 (0.20%)  2 1/1000 (0.10%)  1
Gun shot wound * 1  3/1000 (0.30%)  3 9/1000 (0.90%)  9
Head injury * 1  2/1000 (0.20%)  2 0/1000 (0.00%)  0
Heat exhaustion * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Humerus fracture * 1  2/1000 (0.20%)  2 0/1000 (0.00%)  0
Joint dislocation * 1  2/1000 (0.20%)  2 1/1000 (0.10%)  1
Joint injury * 1  2/1000 (0.20%)  2 1/1000 (0.10%)  1
Joint sprain * 1  1/1000 (0.10%)  1 1/1000 (0.10%)  1
Meniscus lesion * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Polytraumatism * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Radius fracture * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Road traffic accident * 1  0/1000 (0.00%)  0 5/1000 (0.50%)  5
Thermal burn * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Investigations     
Weight decreased * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Metabolism and nutrition disorders     
Hyperuricaemia * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Arthritis reactive * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Back pain * 1  0/1000 (0.00%)  0 3/1000 (0.30%)  3
Costochandritis * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Intervertebrial disc protrution * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Rheumatic fever * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Sacroilitis * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Spinal osteoarthritis * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bile duct cancer * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Nervous system disorders     
Arachnoid cyst * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Cerebellar ataxia * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Convulsion * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Dizziness * 1  1/1000 (0.10%)  1 1/1000 (0.10%)  1
Epilepsy * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Headache * 1  1/1000 (0.10%)  1 1/1000 (0.10%)  1
Pregnancy, puerperium and perinatal conditions     
Pregnancy * 1  1/1000 (0.10%)  1 1/1000 (0.10%)  1
Psychiatric disorders     
Acute stress disorder * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Affective disorder * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Anxiety * 1  2/1000 (0.20%)  2 4/1000 (0.40%)  4
Anxiety disorder * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Renal and urinary disorders     
Calculus bladder * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Glomerulonephritis * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Haematuria * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Nephrolithiasis * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Reproductive system and breast disorders     
Epididymitis * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Phimosis * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Varicocele * 1  2/1000 (0.20%)  2 0/1000 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Nasal septum * 1  3/1000 (0.30%)  3 2/1000 (0.20%)  2
Pleural effusion * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Vocal cord thickening * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Skin and subcutaneous tissue disorders     
Dermatitis * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Eczema nummular * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Photosensitivity reaction * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Social circumstances     
Social stay hospitalisation * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Surgical and medical procedures     
Anal fistula excision * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Haemorrhoid operation * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Hospitalisation * 1  0/1000 (0.00%)  0 2/1000 (0.20%)  2
Surgery * 1  1/1000 (0.10%)  1 1/1000 (0.10%)  1
Vasectomy * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Vascular disorders     
Accelerated hypertension * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Hypertension * 1  1/1000 (0.10%)  1 2/1000 (0.20%)  2
Wound haemorrhage * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
1
Term from vocabulary, MedDRA (Unspecified)
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo 20mcg Recombinant HEV
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   226/1000 (22.60%)      229/1000 (22.90%)    
Blood and lymphatic system disorders     
Eosinophilia * 1  0/1000 (0.00%)  0 2/1000 (0.20%)  2
Congenital, familial and genetic disorders     
Hydrocele * 1  0/1000 (0.00%)  0 2/1000 (0.20%)  2
Ear and labyrinth disorders     
Cerumen impaction * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Ear pain * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Vertigo * 1  2/1000 (0.20%)  2 0/1000 (0.00%)  0
Eye disorders     
Astigmatism * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Blepharitis * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Conjunctivitis * 1  1/1000 (0.10%)  1 1/1000 (0.10%)  1
Eye disorder * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Eye pain * 1  1/1000 (0.10%)  1 1/1000 (0.10%)  1
Gastrointestinal disorders     
Abdominal discomfort * 1  2/1000 (0.20%)  2 1/1000 (0.10%)  1
Abdominal pain * 1  10/1000 (1.00%)  10 15/1000 (1.50%)  15
Abdominal pain upper * 1  2/1000 (0.20%)  2 2/1000 (0.20%)  2
Diarrhoea * 1  22/1000 (2.20%)  22 22/1000 (2.20%)  22
Dyspepsia * 1  7/1000 (0.70%)  7 9/1000 (0.90%)  9
Enteritis * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Food poisoning * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Gastritis * 1  1/1000 (0.10%)  1 4/1000 (0.40%)  4
Haemorrhoids * 1  0/1000 (0.00%)  0 2/1000 (0.20%)  2
Pericoronitis * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Salivary gland mass * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Tooth disorder * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Toothache * 1  2/1000 (0.20%)  2 1/1000 (0.10%)  1
General disorders     
Asthenia * 1  5/1000 (0.50%)  5 6/1000 (0.60%)  6
Chest pain * 1  3/1000 (0.30%)  3 1/1000 (0.10%)  1
Chills * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Fatigue * 1  1/1000 (0.10%)  1 3/1000 (0.30%)  3
Feeling of body temperature change * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Influenza like illness * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Injection site anaesthesia * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Local swelling * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Oedema peripheral * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Pain * 1  5/1000 (0.50%)  5 6/1000 (0.60%)  6
Pyrexia * 1  31/1000 (3.10%)  31 29/1000 (2.90%)  29
Hepatobiliary disorders     
Jaundice hepatocellular * 1  1/1000 (0.10%)  1 2/1000 (0.20%)  2
Immune system disorders     
Hypersensitivity * 1  3/1000 (0.30%)  3 3/1000 (0.30%)  3
Infections and infestations     
Abscess neck * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Acarodermatitis * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Acute sinusitis * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Acute tonsillitis * 1  2/1000 (0.20%)  2 0/1000 (0.00%)  0
Appendicitis * 1  1/1000 (0.10%)  1 1/1000 (0.10%)  1
Ascariasis * 1  1/1000 (0.10%)  1 1/1000 (0.10%)  1
Cellulitis * 1  1/1000 (0.10%)  1 1/1000 (0.10%)  1
Dermatitis infected * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Diarrhoea infectious * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Dysentery * 1  2/1000 (0.20%)  2 3/1000 (0.30%)  3
Empyema * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Encephalitis japanese b * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Fungal infection * 1  0/1000 (0.00%)  0 2/1000 (0.20%)  2
Furuncle * 1  1/1000 (0.10%)  1 1/1000 (0.10%)  1
Gastroenteritis * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Gastroenteritis shigella * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Giardiasis * 1  1/1000 (0.10%)  1 3/1000 (0.30%)  3
Gingival infection * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Helminthic infection * 1  1/1000 (0.10%)  1 2/1000 (0.20%)  2
Hepatitis e * 1  3/1000 (0.30%)  3 4/1000 (0.40%)  4
Herpes zoster * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Infection * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Influenza * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Labyrinthitis * 1  2/1000 (0.20%)  2 1/1000 (0.10%)  1
Leptospirosis * 1  3/1000 (0.30%)  3 1/1000 (0.10%)  1
Lower respiratory tract infection * 1  3/1000 (0.30%)  3 2/1000 (0.20%)  2
Nasopharyngitis * 1  20/1000 (2.00%)  20 22/1000 (2.20%)  22
Otitis media chronic * 1  0/1000 (0.00%)  0 2/1000 (0.20%)  2
Paratyphoid fever * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Pharyngitis * 1  4/1000 (0.40%)  4 3/1000 (0.30%)  3
Respiratory tract infection * 1  1/1000 (0.10%)  1 2/1000 (0.20%)  2
Rhinitis * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Salmonella bacteraemia * 1  1/1000 (0.10%)  1 2/1000 (0.20%)  2
Scrub typhus * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Sinusitis * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Subcutaneous abscess * 1  1/1000 (0.10%)  1 1/1000 (0.10%)  1
Tinea pedis * 1  1/1000 (0.10%)  1 1/1000 (0.10%)  1
Tonsillitis * 1  11/1000 (1.10%)  11 8/1000 (0.80%)  8
Typhoid fever * 1  6/1000 (0.60%)  6 7/1000 (0.70%)  7
Upper respiratory tract infection * 1  15/1000 (1.50%)  15 9/1000 (0.90%)  9
Urinary tract infection * 1  1/1000 (0.10%)  1 1/1000 (0.10%)  1
Viral infection * 1  5/1000 (0.50%)  5 4/1000 (0.40%)  4
Injury, poisoning and procedural complications     
Animal bite * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Face injury * 1  2/1000 (0.20%)  2 0/1000 (0.00%)  0
Gun shot wound * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Hand fracture * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Heat exhaustion * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Joint dislocation * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Joint injury * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Joint sprain * 1  2/1000 (0.20%)  2 2/1000 (0.20%)  2
Laceration * 1  0/1000 (0.00%)  0 2/1000 (0.20%)  2
Limb injury * 1  4/1000 (0.40%)  4 0/1000 (0.00%)  0
Post procedural pain * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Skin laceration * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Tibia fracture * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Wound * 1  1/1000 (0.10%)  1 5/1000 (0.50%)  5
Wound complication * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Metabolism and nutrition disorders     
Anorexia * 1  3/1000 (0.30%)  3 2/1000 (0.20%)  2
Decreased appetite * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  6/1000 (0.60%)  6 7/1000 (0.70%)  7
Back pain * 1  6/1000 (0.60%)  6 4/1000 (0.40%)  4
Bone pain * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Muscle spasms * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Myalgia * 1  2/1000 (0.20%)  2 0/1000 (0.00%)  0
Pain in extremity * 1  1/1000 (0.10%)  1 4/1000 (0.40%)  4
Shoulder pain * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Nervous system disorders     
Burning sensation * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Dizziness * 1  10/1000 (1.00%)  10 4/1000 (0.40%)  4
Headache * 1  43/1000 (4.30%)  43 36/1000 (3.60%)  36
Hypoaesthesia * 1  3/1000 (0.30%)  3 0/1000 (0.00%)  0
Paraesthesia * 1  1/1000 (0.10%)  1 1/1000 (0.10%)  1
Psychiatric disorders     
Anxiety * 1  1/1000 (0.10%)  1 4/1000 (0.40%)  4
Anxiety disorder * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Renal and urinary disorders     
Chromaturia * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Dysuria * 1  0/1000 (0.00%)  0 2/1000 (0.20%)  2
Neophrolithiasis * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Reproductive system and breast disorders     
Pruritus genital * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Testicular pain * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Varicocele * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Cough * 1  8/1000 (0.80%)  8 8/1000 (0.80%)  8
Pharyngolaryngeal pain * 1  0/1000 (0.00%)  0 4/1000 (0.40%)  4
Rhinorrhoea * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Skin and subcutaneous tissue disorders     
Acne * 1  0/1000 (0.00%)  0 2/1000 (0.20%)  2
Alopecia * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Dermatitis * 1  1/1000 (0.10%)  1 1/1000 (0.10%)  1
Dermatitis allergic * 1  2/1000 (0.20%)  2 0/1000 (0.00%)  0
Eczema * 1  1/1000 (0.10%)  1 1/1000 (0.10%)  1
Hyperkeratosis * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Lichenoid keratosis * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Pruritus * 1  2/1000 (0.20%)  2 2/1000 (0.20%)  2
Pruritus generalised * 1  1/1000 (0.10%)  1 3/1000 (0.30%)  3
Rash * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
Rash erythematous * 1  0/1000 (0.00%)  0 1/1000 (0.10%)  1
Surgical and medical procedures     
Hospitalisation * 1  0/1000 (0.00%)  0 2/1000 (0.20%)  2
Tooth extraction * 1  1/1000 (0.10%)  1 2/1000 (0.20%)  2
Vasectomy * 1  1/1000 (0.10%)  1 1/1000 (0.10%)  1
Wart excision * 1  1/1000 (0.10%)  1 0/1000 (0.00%)  0
1
Term from vocabulary, MedDRA (Unspecified)
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Mrigendra P. Shrestha MD
Organization: Armed Forces Research Institute of Medical Services
Phone: 662-644-4888
EMail: shrestham@afrims.org
Layout table for additonal information
Responsible Party: U.S. Army Medical Research and Development Command
ClinicalTrials.gov Identifier: NCT00287469    
Other Study ID Numbers: WRAIR 749
HSRRB A-9117.1
GSK 304558/003 (HEV-003)
IND 7815 ( Other Identifier: FDA )
First Submitted: February 2, 2006
First Posted: February 6, 2006
Results First Submitted: October 9, 2018
Results First Posted: May 29, 2019
Last Update Posted: May 29, 2019