HIV Infections Clinical Trial
Official title:
A Phase I Double-Blind, Randomized, Placebo-Controlled, Dose-Escalation Trial to Evaluate the Safety and Immunogenicity of a Sendai HIV Vaccine SeV-G(NP) Given Intranasally and Ad35-GRIN Administered Intramuscularly in Prime-Boost Regimens in HIV-Uninfected, Healthy Adult Volunteers
NCT number | NCT01705990 |
Other study ID # | IAVI S001 |
Secondary ID | |
Status | Completed |
Phase | Phase 1 |
First received | October 10, 2012 |
Last updated | August 25, 2015 |
Start date | March 2013 |
The purpose of this study is to evaluate the safety, tolerability and immunogenicity of Sendai HIV vaccine SeV-G(NP) given intranasally and Ad35-GRIN administered intramuscularly in prime-boost regimens in HIV-uninfected, healthy adult volunteers.
Status | Completed |
Enrollment | 65 |
Est. completion date | |
Est. primary completion date | March 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: - healthy male or female adults, - 18 to 50 years of age (21 to 50 years of age for volunteers in Rwanda), - who do not report high-risk behaviour for HIV infection, - who are available for the duration of the trial, - who are willing to undergo HIV testing, - use an effective method of contraception, and - who, in the opinion of the principal investigator or designee, understand the study and who provide written informed consent. Exclusion Criteria: - confirmed HIV infection, - pregnancy and lactation, - significant acute or chronic disease, - clinically significant laboratory abnormalities, - recent vaccination or receipt of a blood product, - previous receipt of an HIV vaccine, and - previous severe local or systemic reactions to vaccination or history of severe allergic reactions. |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Kenya | Kenya AIDS Vaccine Initiative | Nairobi | |
Rwanda | Project San Francisco | Kigali | |
United Kingdom | St. Stephen's Centre | London |
Lead Sponsor | Collaborator |
---|---|
International AIDS Vaccine Initiative |
Kenya, Rwanda, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with adverse events as a measure of safety and tolerability | To evaluate the safety and tolerability of SeV-G(NP) and Ad35-GRIN administered in four prime-boost regimens. | 16 months approximately | Yes |
Secondary | Shedding | To assess the presence and persistence of the SeV-G(NP) vector and the in vivo genetic integrity of the insert | 16 months | No |
Secondary | Immunogenicity | To assess (qualitative and quantitative) immune responses elicited by the different prime-boost regimens. | 16 months | No |
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