Safety and Immunogenicity Study of 2 Investigational Preventive HIV Vaccines

NCT01264445 | Completed Phase 1 DMC

• 1 other identifier: IAVI B002
• Study Type: interventional
• Target: 147
• Locations: 3 countries
• Sites: 4

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of an adjuvanted GSK investigational HIV vaccine and Ad35-GRIN in 4 different regimens at months 1, 2, 3, and 4.

Conditions

HIV Infections

Keywords

HIV

Outcome Measures

Primary Outcomes (1)

• Safety of an adjuvanted HIV protein vaccine in prime-boost combinations with AD35-GRIN or coadministered with AD35-GRIN

  Safety of an adjuvanted (dose escalation for adjvans) HIV protein vaccine given as prime or boost in combination with Ad35-GRIN or co-administered with Ad35-GRIN

  16 months

Secondary Outcomes (1)

• Immunogenicity of an adjuvanted HIV protein vaccine given in different prime-boost regimens with Ad35-GRIN or coadminisitered with Ad35-GRIN

  16 months

Study Arms (4)

Group A

EXPERIMENTAL

Adjuvanted GSK investigational HIV vaccine at Months 0 and 1 followed by Ad35-GRIN investigational HIV vaccine at Month 4.

Biological: Adjuvanted GSK investigational HIV vaccine formulation 1; Biological: Ad35 investigational HIV vaccine; Biological: Placebo (saline)

Group B

EXPERIMENTAL

Adjuvanted GSK investigational HIV vaccine at Months 0 and 1 followed by Ad35-GRIN investigational HIV vaccine at Month 4.

Biological: Adjuvanted GSK investigational HIV vaccine formulation 2; Biological: Ad35 investigational HIV vaccine; Biological: Placebo (saline)

Group C

EXPERIMENTAL

Ad35-GRIN investigational HIV vaccine at Month 0 followed by Adjuvanted GSK investigational HIV vaccine at Months 3 and 4.

Biological: Ad35 investigational HIV vaccine; Biological: Adjuvanted GSK investigational HIV vaccine formulation 2; Biological: Placebo (saline)

Group D

EXPERIMENTAL

Adjuvanted GSK investigational HIV vaccine and Ad35-GRIN investigational HIV vaccine co-administered (simultaneous administration with separate injections)at Months 0, 1, and 4.

Biological: Adjuvanted GSK investigational HIV vaccine formulation 2; Biological: Ad35 investigational HIV vaccine; Biological: Placebo (saline)

Interventions

Adjuvanted GSK investigational HIV vaccine formulation 1 BIOLOGICAL

Receive at Months 0 and 1

Group A

Adjuvanted GSK investigational HIV vaccine formulation 2 BIOLOGICAL

Receive at Months 0 and 1

Group B

Ad35 investigational HIV vaccine BIOLOGICAL

Receive at Month 0

Group C

Placebo (saline) BIOLOGICAL

(Vaccine:Placebo=28:7) Groups A, B, C, and D will all have a placebo comparator component (7 volunteers will receive placebo in each group at the specified months.)

Group A; Group B; Group C; Group D

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males and females, as assessed by a medical history, physical exam, and laboratory tests
• At least 18 years of age on the day of screening and has not reached his/her 41st birthday on the day of first vaccination
• Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study (screening plus 16 months)
• In the opinion of the Principal Investigator or designee and based on Assessment of Informed Consent Understanding results, has understood the information provided and potential risks linked to vaccination and participation in the trial. Written informed consent needs to be provided by the volunteer before any study-related procedures are performed
• Willing to undergo HIV testing, risk reduction counselling, receive HIV test results and committed to maintaining low risk behaviour for the trial duration
• If a female of childbearing potential (not menopausal or anatomically sterile), willing to use an effective non-barrier method of contraception (hormonal contraceptive; intra-uterine device), from screening until four months after last vaccination. All female volunteers must be willing to undergo urine pregnancy tests at time points as indicated in the study protocol and must test negative prior to each vaccination.
• If sexually active male (who is not anatomically sterile), willing to use an effective method of contraception (such as consistent condom use) from the day of first vaccination until 4 months after the last vaccination
• Willing to forgo donations of blood or any other tissues during the study and, for those who test HIV positive after vaccination, until the anti-HIV antibody titres become undetectable

You may not qualify if:

• Confirmed HIV-1 or HIV-2 infection
• Any clinically relevant abnormality on history or examination including history of immunodeficiency, malignancy or autoimmune disease; use of systemic corticosteroids (\<2 weeks use of topical or inhaled steroids is permitted); immunosuppressive, anticancer, anti-tuberculosis or other medications considered significant by the investigator within the previous 6 months
• Any clinically significant acute or chronic medical condition that is considered progressive, or in the opinion of the investigator, makes the volunteer unsuitable for participation in the study
• Detection of Ad35-specific serum neutralizing antibody
• Reported high-risk behaviour for HIV infection within 6 months prior to first vaccination, as defined by the protocol.
• If female, pregnant or planning a pregnancy within 4 months after last vaccination; or lactating
• Unstable asthma (e.g. sudden acute attacks occurring without an obvious trigger) or asthma requiring:
• Daily steroid or long acting beta-agonist prevention
• Hospitalization in the last two years
• Bleeding disorder that was diagnosed by a physician e.g., factor deficiency, coagulopathy or platelet disorder that requires special precautions. (A volunteer who states that he or she has easy bruising or bleeding, but does not have a formal diagnosis and has intramuscular (IM) injections and blood draws without any adverse experience is eligible)
• History of splenectomy
• Any abnormal laboratory parameters as defined by the protocol;
• Receipt of live-attenuated vaccine within the previous 60 days (live attenuated flu vaccine within 14 days) or planned receipt within 60 days after vaccination with Investigational Product; or receipt of other vaccine (e.g. pneumococcal), allergy treatment with antigen injections or tuberculin skin test within the previous 14 days or planned receipt within 14 days after vaccination with Investigational Product
• Receipt of blood transfusion or blood-derived products within the previous 6 months
• Participation in another clinical trial of an Investigational Product currently, within the previous 3 months or expected participation during this study

Sponsors & Collaborators

• International AIDS Vaccine Initiative: lead
• GlaxoSmithKline: collaborator

Study Sites (4)

Kenya AIDS Vaccine Initiative

Nairobi, Kenya

Location

Uganda Virus Research Institute-IAVI

Entebbe, Uganda

Location

Medical Research Council

Masaka, Uganda

Location

Zambia-Emory HIV Research Project

Lusaka, Zambia

Location

Related Publications (1)

• Omosa-Manyonyi G, Mpendo J, Ruzagira E, Kilembe W, Chomba E, Roman F, Bourguignon P, Koutsoukos M, Collard A, Voss G, Laufer D, Stevens G, Hayes P, Clark L, Cormier E, Dally L, Barin B, Ackland J, Syvertsen K, Zachariah D, Anas K, Sayeed E, Lombardo A, Gilmour J, Cox J, Fast P, Priddy F. A Phase I Double Blind, Placebo-Controlled, Randomized Study of the Safety and Immunogenicity of an Adjuvanted HIV-1 Gag-Pol-Nef Fusion Protein and Adenovirus 35 Gag-RT-Int-Nef Vaccine in Healthy HIV-Uninfected African Adults. PLoS One. 2015 May 11;10(5):e0125954. doi: 10.1371/journal.pone.0125954. eCollection 2015.

  PMID: 25961283 DERIVED

Related Links

• International AIDS Vaccine Initiative

MeSH Terms

Conditions

HIV Infections

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Gloria S Omosa-Manyonyi, MBChB,DPH,DLSHTM, MSc.

  Kenya AIDS Vaccine Initiative

  PRINCIPAL INVESTIGATOR

• Juliet Mpendo, MBChB, MPH

  Uganda Virus Research Institute-IAVI

  PRINCIPAL INVESTIGATOR

• Eugene Ruzagira, MBChB MPH

  Medical Research Council-UVRI Uganda Research Unit on AIDS

  PRINCIPAL INVESTIGATOR

• Elwyn Chomba, BSc, MBChB, DCH, MRCP

  Zambia-Emory HIV Research Project

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2010
• First Posted: December 21, 2010
• Study Start: February 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: February 11, 2013

Record last verified: 2013-02

Locations

KE (1); UG (2); ZA (1)