Study to Evaluate the Dosage and Safety of Two Intramuscular Injections of an Investigational Clade B HIV Vaccine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Institut Pasteur
ClinicalTrials.gov Identifier:
NCT01320176
First received: March 21, 2011
Last updated: February 13, 2012
Last verified: February 2012
  Purpose

This study aimed to evaluate the safety and reactogenicity of two intramuscular injections of two different dosages of an investigational clade B HIV vaccine.


Condition Intervention Phase
HIV
Biological: Investigational HIV vaccine dose A
Biological: Investigational HIV vaccine dose B
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: An Open-label, Phase I, Dose-escalation and Safety Study of Two Intramuscular Injections of a Dose of 2.9 Log or 4 Log CCID50 of the Recombinant HIV I Clade B Measles Vaccine Vector in Healthy Adults.

Resource links provided by NLM:


Further study details as provided by Institut Pasteur:

Primary Outcome Measures:
  • Occurrence, intensity and relationship to vaccination of solicited local and general adverse events (AEs) except fever [ Time Frame: 14-day follow-up after each vaccination ] [ Designated as safety issue: No ]
  • Occurrence, intensity and relationship to vaccination of fever [ Time Frame: 21-day follow-up after each vaccination ] [ Designated as safety issue: No ]
  • Occurrence, intensity and relationship to vaccination of unsolicited adverse events (AEs) [ Time Frame: 42-day follow-up after each vaccination ] [ Designated as safety issue: No ]
  • Occurrence and relationship to vaccination of any serious AEs (SAEs) [ Time Frame: During the study period (Month 0-11) ] [ Designated as safety issue: No ]
  • Occurrence, intensity and relationship to vaccination of clinically significant abnormal haematology and biochemistry values (grade 3 or 4) [ Time Frame: During the study period (Month 0-11) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of shedding of recombinant virus [ Time Frame: During the study period (Month 0-11) ] [ Designated as safety issue: No ]
  • Recombinant virus infectivity [ Time Frame: During the study period (Month 0-11) ] [ Designated as safety issue: No ]
  • Cell-mediated immune response (CMI) [ Time Frame: At day 0, 7, 14, 28, 91, 98, 112, 266 ] [ Designated as safety issue: No ]
  • Humoral immune response to HIV antigens [ Time Frame: At day 14, 28, 84, 98, 112, 266. ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: October 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Subjects received dose A of the investigational HIV vaccine
Biological: Investigational HIV vaccine dose A
The vaccine will be administered by intramuscular route into the deltoid muscle preferentially of the non dominant arm at Month 0 and Month 3
Experimental: Group B
Subjects received dose B of the investigational HIV vaccine
Biological: Investigational HIV vaccine dose B
The vaccine will be administered by intramuscular route into the deltoid muscle preferentially of the non dominant arm at Month 0 and Month 3

  Eligibility

Ages Eligible for Study:   18 Years to 27 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subjects who the investigator believes can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) and are available for all scheduled visits at the investigational site
  2. Adult male and or female subjects between 18 and 27 years old.
  3. Proven record of measles vaccination (longer than 5 years)
  4. Measles antibodies titre < 350 IU/L or > 750 IU/L measured in the previous study "CEVAC sero-MV-001".
  5. Healthy subjects as established by medical history and clinical examination before entering into the study.
  6. Confirmed HIV negative based on the absence of antibodies and p24.
  7. Negative for Hepatitis B surface (HBs) antigen, anti-hepatitis B core (HBc antibodies) antibody and anti-Hepatitis C Virus (HCV) antibody

Exclusion Criteria:

  1. Participation in another clinical study in the last 6 months in which the subject has been exposed to an investigational product (pharmaceutical product or placebo or device) or concurrent participation in another clinical study during the study period.
  2. Previous inclusion in an HIV vaccine study.
  3. Receipt of any other vaccination 1 month before or planning to receive any vaccination 1 month after each study vaccination
  4. Receipt of tuberculin skin test 1 month before or planning to receive a tuberculin test 1 month after each study vaccination
  5. Receipt of allergy treatment with antigen injections 1 month before or planning to receive allergy treatment with antigen injections 1 month after each study vaccination
  6. Receipt of blood products or immunoglobulins within 120 days prior to enrolment.
  7. Measles vaccination or booster within the last 5 years as confirmed by medical history.
  8. Subject is pregnant or breastfeeding or intends to become pregnant within 9 months of enrolling into the study.
  9. Subject is of childbearing potential and does not agree to use a medically acceptable form of contraception for the duration of the study (9 months post the first investigational HIV vaccination). Medically acceptable forms of contraception include: Contraceptive Medication, Intrauterine device, Double barrier method (Condom* and Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.

    * A female condom and a male condom should not be used together as friction between the two can result in either product failing.

  10. History of any significant immunodeficient condition.
  11. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within the 6 months prior to the first vaccination
  12. Individuals who are at high risk of acquired HIV infection as determined by the risk assessment questionnaire.
  13. Individuals who are living and/or working with severely immunocompromised people, children under 15 months old or pregnant women.
  14. Family history of immunodeficiency and/or personal history of autoimmune disease (including psoriasis, rheumatoid arthritis, autoimmune thyroid disease).
  15. History of type I or type II diabetes mellitus including cases controlled with diet alone.
  16. History or ongoing malignancy.
  17. Major congenital defects or serious chronic illness at the time of enrolment.
  18. History of serious adverse reactions to vaccine administration, including anaphylaxis and related symptoms, such as urticaria, respiratory difficulty, angioedema and abdominal pain to vaccines, or history of allergic reaction likely to be exacerbated by any component of the vaccine.
  19. Acute or chronic, clinically significant, as determined by the investigator, pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
  20. Individuals whose Body Mass index (BMI) is less than 18.5 or greater than 30 (i.e. underweight or obese).
  21. History of clinically significant, as determined by the investigator, neurological disorder or seizures.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01320176

Locations
Belgium
Gent University & Hospital, Center for Vaccinology
Gent, Belgium, 9000
Sponsors and Collaborators
Institut Pasteur
Investigators
Principal Investigator: Geert - Leroux-Roels, MD Geert.lerouxRoels@UGent.be
  More Information

No publications provided

Responsible Party: Institut Pasteur
ClinicalTrials.gov Identifier: NCT01320176     History of Changes
Other Study ID Numbers: MV1-F4-CT1
Study First Received: March 21, 2011
Last Updated: February 13, 2012
Health Authority: Belgium: Federal Agency for Medicines and Healthcare Products

ClinicalTrials.gov processed this record on September 14, 2014