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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 65
- Locations
- 3
- Primary Endpoint
- Number of participants with adverse events as a measure of safety and tolerability
Study Overview
Brief Summary
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.
Detailed Description
The study is a randomized, double-blind, placebo-controlled, dose-escalation trial assessing the safety, tolerability, and immunogenicity of SeV-G(NP) given intranasally by drops and Ad35-GRIN administered intramuscularly in each of four prime-boost regimens.
Volunteers will be screened up to 42 days before the 1st vaccination and will be followed for 12 months after the last vaccine administration (16 months after the first vaccination). It is anticipated that it will take approximately 6 months to enroll the study. Approximately 64 volunteers (48 vaccine and 16 placebo recipients) will be included in the study.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Group A: SeV-G(NP) followed by Ad35-GRIN
SeV-G(NP) (IN) at 2x10^7 CIU at Month 0 followed by Ad35-GRIN (IM) at 1x10^10 vp at Month 4. (Vaccine/Placebo = 12/4)
Intervention: SeV-G(NP) (0.2mL, 2x10^7 CIU) (Biological)
Group A: SeV-G(NP) followed by Ad35-GRIN
SeV-G(NP) (IN) at 2x10^7 CIU at Month 0 followed by Ad35-GRIN (IM) at 1x10^10 vp at Month 4. (Vaccine/Placebo = 12/4)
Intervention: Ad35-GRIN (0.5mL) (Biological)
Group B: SeV-G(NP) followed by Ad35-GRIN
SeV-G(NP) (IN) at 2x10^8 CIU at Month 0 followed by Ad35-GRIN (IM) at 1x10^10 vp at Month 4. (Vaccine/Placebo = 12/4)
Intervention: SeV-G(NP) (0.2mL, 2x10^8 CIU) (Biological)
Group B: SeV-G(NP) followed by Ad35-GRIN
SeV-G(NP) (IN) at 2x10^8 CIU at Month 0 followed by Ad35-GRIN (IM) at 1x10^10 vp at Month 4. (Vaccine/Placebo = 12/4)
Intervention: Ad35-GRIN (0.5mL) (Biological)
Group C: Ad35-GRIN followed by SeV-G(NP)
Ad35-GRIN (IM) at 1x10^10 vp at Month 0 followed by SeV-G(NP) (IN) at 2x10^8 CIU at Month 4. (Vaccine/Placebo = 12/4)
Intervention: SeV-G(NP) (0.2mL, 2x10^8 CIU) (Biological)
Group C: Ad35-GRIN followed by SeV-G(NP)
Ad35-GRIN (IM) at 1x10^10 vp at Month 0 followed by SeV-G(NP) (IN) at 2x10^8 CIU at Month 4. (Vaccine/Placebo = 12/4)
Intervention: Ad35-GRIN (0.5mL) (Biological)
Group D: SeV-G(NP) only
SeV-G(NP) (IN) at 2x10^8 CIU at Month 0 and 4. (Vaccine/Placebo = 12/4)
Intervention: SeV-G(NP) (0.2mL, 2x10^8 CIU) (Biological)
Outcomes
Primary Outcomes
Number of participants with adverse events as a measure of safety and tolerability
Time Frame: 16 months approximately
To evaluate the safety and tolerability of SeV-G(NP) and Ad35-GRIN administered in four prime-boost regimens.
Secondary Outcomes
- Immunogenicity(16 months)
- Shedding(16 months)