Clinical trial NCT01705990: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Keywords: HIV
AIDS
HIV vaccine
HIV prevention
Lead sponsor: International AIDS Vaccine Initiative
Sponsor class: NETWORK
First posted: 2012-10-15
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with adverse events as a measure of safety and tolerability
timeFrame: 16 months approximately
Secondary outcomes:
measure: Shedding
timeFrame: 16 months
measure: Immunogenicity
timeFrame: 16 months
Other outcomes:
Locations:
city: Nairobi
country: Kenya
facility: Kenya AIDS Vaccine Initiative
city: Kigali
country: Rwanda
facility: Project San Francisco
city: London
country: United Kingdom
facility: St. Stephen's Centre
Study officials:
References:
citation: Nyombayire J, Anzala O, Gazzard B, Karita E, Bergin P, Hayes P, Kopycinski J, Omosa-Manyonyi G, Jackson A, Bizimana J, Farah B, Sayeed E, Parks CL, Inoue M, Hironaka T, Hara H, Shu T, Matano T, Dally L, Barin B, Park H, Gilmour J, Lombardo A, Excler JL, Fast P, Laufer DS, Cox JH; S001 Study Team. First-in-Human Evaluation of the Safety and Immunogenicity of an Intranasally Administered Replication-Competent Sendai Virus-Vectored HIV Type 1 Gag Vaccine: Induction of Potent T-Cell or Antibody Responses in Prime-Boost Regimens. J Infect Dis. 2017 Jan 1;215(1):95-104. doi: 10.1093/infdis/jiw500. Epub 2016 Oct 17.