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

NCT01320176 | Completed Phase 1

• 1 other identifier: MV1-F4-CT1
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

HIV

Outcome Measures

Primary Outcomes (5)

• Occurrence, intensity and relationship to vaccination of solicited local and general adverse events (AEs) except fever

  14-day follow-up after each vaccination

• Occurrence, intensity and relationship to vaccination of fever

  21-day follow-up after each vaccination

• Occurrence, intensity and relationship to vaccination of unsolicited adverse events (AEs)

  42-day follow-up after each vaccination

• Occurrence and relationship to vaccination of any serious AEs (SAEs)

  During the study period (Month 0-11)

• Occurrence, intensity and relationship to vaccination of clinically significant abnormal haematology and biochemistry values (grade 3 or 4)

  During the study period (Month 0-11)

Secondary Outcomes (4)

• Occurrence of shedding of recombinant virus

  During the study period (Month 0-11)

• Recombinant virus infectivity

  During the study period (Month 0-11)

• Cell-mediated immune response (CMI)

  At day 0, 7, 14, 28, 91, 98, 112, 266

• Humoral immune response to HIV antigens

  At day 14, 28, 84, 98, 112, 266.

Study Arms (2)

Group A

EXPERIMENTAL

Subjects received dose A of the investigational HIV vaccine

Biological: Investigational HIV vaccine dose A

Group B

EXPERIMENTAL

Subjects received dose B of the investigational HIV vaccine

Biological: Investigational HIV vaccine dose B

Interventions

Investigational HIV vaccine dose A BIOLOGICAL

The vaccine will be administered by intramuscular route into the deltoid muscle preferentially of the non dominant arm at Month 0 and Month 3

Group A

Investigational HIV vaccine dose B BIOLOGICAL

The vaccine will be administered by intramuscular route into the deltoid muscle preferentially of the non dominant arm at Month 0 and Month 3

Group B

Eligibility Criteria

• Age: 18 Years - 27 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Adult male and or female subjects between 18 and 27 years old.
• Proven record of measles vaccination (longer than 5 years)
• Measles antibodies titre \< 350 IU/L or \> 750 IU/L measured in the previous study "CEVAC sero-MV-001".
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• Confirmed HIV negative based on the absence of antibodies and p24.
• Negative for Hepatitis B surface (HBs) antigen, anti-hepatitis B core (HBc antibodies) antibody and anti-Hepatitis C Virus (HCV) antibody

You may not qualify if:

• 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.
• Receipt of any other vaccination 1 month before or planning to receive any vaccination 1 month after each study vaccination
• Receipt of tuberculin skin test 1 month before or planning to receive a tuberculin test 1 month after each study vaccination
• 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
• Receipt of blood products or immunoglobulins within 120 days prior to enrolment.
• Measles vaccination or booster within the last 5 years as confirmed by medical history.
• Subject is pregnant or breastfeeding or intends to become pregnant within 9 months of enrolling into the study.
• 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.
• History of any significant immunodeficient condition.
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within the 6 months prior to the first vaccination
• Individuals who are at high risk of acquired HIV infection as determined by the risk assessment questionnaire.
• Individuals who are living and/or working with severely immunocompromised people, children under 15 months old or pregnant women.
• Family history of immunodeficiency and/or personal history of autoimmune disease (including psoriasis, rheumatoid arthritis, autoimmune thyroid disease).
• History of type I or type II diabetes mellitus including cases controlled with diet alone.

Sponsors & Collaborators

• Institut Pasteur: lead

Study Sites (1)

Gent University & Hospital, Center for Vaccinology

Ghent, 9000, Belgium

Location

Study Officials

• Geert - Leroux-Roels, MD

  Geert.lerouxRoels@UGent.be

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2011
• First Posted: March 22, 2011
• Study Start: October 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: February 14, 2012

Record last verified: 2012-02

Locations

BE (1)