Study of the Safety and Immunogenicity of H1N1 Vaccine

This study has been completed.
Sponsor:
Collaborators:
Walter Reed Army Institute of Research (WRAIR)
Defense Advanced Research Projects Agency
Information provided by (Responsible Party):
Walter Reed Army Institute of Research (WRAIR) ( Fraunhofer USA Center for Molecular Biotechnology (FhCMB) )
ClinicalTrials.gov Identifier:
NCT01177202
First received: August 5, 2010
Last updated: November 30, 2012
Last verified: November 2012

August 5, 2010
November 30, 2012
September 2010
May 2011   (final data collection date for primary outcome measure)
To assess the safety, reactogenicity, and tolerability of the HAC1 vaccine formulations. [ Time Frame: Six Months ] [ Designated as safety issue: Yes ]
The primary objective of this study is to assess the safety, reactogenicity, and tolerability of the HAC1 vaccine formulations delivered intramuscularly at doses of 15 μg, 45 μg or 90 µg (unadjuvanted or adjuvanted) in healthy adults 18 - 50 years of age.
Same as current
Complete list of historical versions of study NCT01177202 on ClinicalTrials.gov Archive Site
To assess and compare the immunogenicity to 2 injections of the 6 HAC1 vaccine formulations. [ Time Frame: Six Months ] [ Designated as safety issue: No ]
The secondary objective is to assess and compare the immunogenicity to 2 injections of the 6 HAC1 vaccine formulations using existing research assays and by measuring hemagglutination inhibition (HAI) titers.
Same as current
Not Provided
Not Provided
 
Study of the Safety and Immunogenicity of H1N1 Vaccine
A Phase I Dose-Escalation Study to Investigate the Safety and Immunogenicity of the Fusion Protein Recombinant Influenza A (HAC1) Vaccine Derived From Influenza A/California/04/09 (H1N1) in Healthy Adults

The Purpose Of This Study Is To Assess The Safety, Immunogenicity, And Tolerability Of A H1N1 Vaccine In Healthy Adults

This is a single center, placebo-controlled, single blinded dose escalation study to preliminarily assess the safety, reactogenicity, and immunogenicity of different HAC1 vaccine formulations. This study will assess a novel HAC1 vaccine, which is plant derived. This vaccine will be compared to Placebo of normal (0.9%) saline, and reference vaccine consisting of an approved monovalent vaccine containing an A/California (H1N1)-like strain.

Subjects will receive 2 intramuscular injections of the experimental vaccine, placebo, or reference vaccine on Study Days 0 and 21

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
H1N1 Flu
Biological: HAC1 Vaccine
Subjects will come to the Clinical Trials Center up to 7 days prior to each vaccine dose to have blood drawn for research assays. The first dose of vaccine will be given on Day 0 and the second dose will be given 21 days later (± 3 days). Dose escalation will be staggered by at least 7 days as shown in Figure 1. Subjects from Groups G and H will be vaccinated with each of the other 6 groups. Two subjects from group A will be immunized on study day -1. The immunizations will be performed one hour apart with close monitoring. The remaining eight subjects from Group A will be immunized on study day 0. All subsequent immunizations for each group will occur on the same day. The principal investigator and the medical monitor will review all adverse events and make a determination on whether it is safe to proceed to the next higher dosage group. The control and reference vaccine groups can be vaccinated starting anytime after screening.
  • Experimental: Group A
    HAC1 Dose = 15ug; Alum Dose = 0
    Intervention: Biological: HAC1 Vaccine
  • Experimental: Group B
    HAC1 Dose = 15ug; Alum Dose = 0.75mg
    Intervention: Biological: HAC1 Vaccine
  • Experimental: Group C
    HAC1 Dose = 45ug; Alum Dose = 0
    Intervention: Biological: HAC1 Vaccine
  • Experimental: Group D
    HAC1 Dose = 45ug; Alum Dose = 0.75mg
    Intervention: Biological: HAC1 Vaccine
  • Experimental: Group E
    HAC1 Dose = 90ug; Alum Dose = 0
    Intervention: Biological: HAC1 Vaccine
  • Experimental: Group F
    HAC1 Dose = 90ug; Alum Dose = 0.75mg
    Intervention: Biological: HAC1 Vaccine
  • Placebo Comparator: Group G
    Saline
    Intervention: Biological: HAC1 Vaccine
  • Active Comparator: Group H
    H1N1
    Intervention: Biological: HAC1 Vaccine
Cummings JF, Guerrero ML, Moon JE, Waterman P, Nielsen RK, Jefferson S, Gross FL, Hancock K, Katz JM, Yusibov V; Fraunhofer USA Center for Molecular Biotechnology Study Group. Safety and immunogenicity of a plant-produced recombinant monomer hemagglutinin-based influenza vaccine derived from influenza A (H1N1)pdm09 virus: a Phase 1 dose-escalation study in healthy adults. Vaccine. 2014 Apr 17;32(19):2251-9. doi: 10.1016/j.vaccine.2013.10.017. Epub 2013 Oct 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
October 2012
May 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female aged 18 - 50 years inclusive
  • Able to give written informed consent to participate
  • Score of at least 80% correct on a 10 question multiple-choice quiz (2 attempts)
  • Healthy, as determined by medical history, physical examination, weight, vital signs, and clinical safety laboratory examinations at baseline
  • Females must fulfill one of the following criteria: At least one year post-menopausal; Surgically sterile or have a surgically sterile partner; Willing to abstain from sexual intercourse; Willing to use a reliable form of contraception approved by the investigator (e.g., oral, implantable, transdermal or injectable contraceptives, intrauterine device (IUD), female condom, diaphragm with spermicide, cervical cap, or male condoms) for 30 days prior to first vaccination through 3 months after second vaccination
  • Women of childbearing potential must have a negative urine pregnancy test within 24 hours preceding receipt of each dose
  • Comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits and to be contacted by telephone throughout the follow-up period

Exclusion Criteria:

  • Prior receipt of 2010-2011 seasonal influenza vaccine containing A/California/04/09-like virus
  • Screening H1N1 titer of > 1:40
  • Presence of significant uncontrolled medical or psychiatric illness (acute or chronic) including institution of new medical or surgical treatment or a significant dose alteration for uncontrolled symptoms or drug toxicity within 3 months of screening
  • Presence of any medical condition that may be associated with impaired immune responsiveness, including diabetes mellitus
  • Cancer, or treatment for cancer, within the previous 3 years, excluding basal cell carcinoma or squamous cell carcinoma
  • Presently receiving or history of receiving, during the preceding 3-month period, any medications or other treatments that may adversely affect the immune system: This includes allergy injections, immune globulin, interferon, immunomodulators, cytotoxic drugs or other drugs known to be frequently associated with significant major organ toxicity, or systemic corticosteroids (oral or injectable); Inhaled and topical corticosteroids will be allowed
  • Receipt of blood or blood products 8 weeks prior to vaccination or planned administration during the study period
  • Donation of blood or blood products within 8 weeks prior to vaccination or at any time during the study
  • Receipt or planned administration of a nonstudy vaccine within 30 days prior to vaccination; Immunization on an emergency basis with Tetanus Toxoids Adsorbed for adult use (Td or Tdap) vaccine up to 8 days before or at least 8 days after a dose of study vaccine will be allowed
  • History of anaphylactic type reaction to injected vaccines
  • Receipt of any investigational product or nonregistered drug within the 30 days prior to vaccination or currently enrolled in any investigational drug study or intends to enroll in such a study within the ensuing study period
  • History of drug or chemical abuse in the year before the study
  • Positive serology for HIV-1 or HIV-2, or HBsAg or HCV antibodies
  • Unwilling to allow storage of specimens for future use
  • Acute disease within 72 hours prior to vaccination: Acute disease is defined as the presence of a moderate or severe illness (as determined by the Investigator through medical history and physical examination) with or without fever (>38ºC />100.4ºF), or an oral temperature of >38ºC orally; Study vaccine can be administered to persons with a minor illness.
  • Any condition that, in the opinion of the investigator, might interfere with interpretation of data supporting the primary study objectives
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01177202
WRAIR 1758
No
Walter Reed Army Institute of Research (WRAIR) ( Fraunhofer USA Center for Molecular Biotechnology (FhCMB) )
Fraunhofer USA Center for Molecular Biotechnology (FhCMB)
  • Walter Reed Army Institute of Research (WRAIR)
  • Defense Advanced Research Projects Agency
Principal Investigator: James F Cummings, MD, LTC(P), MC, USA Walter Reed Army Institute of Research (WRAIR)
Walter Reed Army Institute of Research (WRAIR)
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP