Safety and Immunogenicity Study of SeV-G(NP) HIV Vaccine Administered Intranasally and Ad35-GRIN HIV Vaccine Given Intramuscularly in Prime-Boost Regimens in HIV-Uninfected Volunteers

International AIDS Vaccine Initiative

Status and phase: Completed; Phase 1

Conditions: HIV Infections

Treatments: Biological: Ad35-GRIN (0.5mL); Biological: SeV-G(NP) (0.2mL, 2x10^7 CIU); Biological: SeV-G(NP) (0.2mL, 2x10^8 CIU)

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT01705990

IAVI S001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 65 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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65 participants in 4 patient groups

Group A: SeV-G(NP) followed by Ad35-GRIN

Experimental group

Description:

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)

Treatment:

Biological: SeV-G(NP) (0.2mL, 2x10^7 CIU)

Biological: Ad35-GRIN (0.5mL)

Group B: SeV-G(NP) followed by Ad35-GRIN

Experimental group

Description:

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)

Treatment:

Biological: SeV-G(NP) (0.2mL, 2x10^8 CIU)

Biological: Ad35-GRIN (0.5mL)

Group C: Ad35-GRIN followed by SeV-G(NP)

Experimental group

Description:

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)

Treatment:

Biological: SeV-G(NP) (0.2mL, 2x10^8 CIU)

Biological: Ad35-GRIN (0.5mL)

Group D: SeV-G(NP) only

Experimental group

Description:

SeV-G(NP) (IN) at 2x10\^8 CIU at Month 0 and 4. (Vaccine/Placebo = 12/4)

Treatment:

Biological: SeV-G(NP) (0.2mL, 2x10^8 CIU)