A Trial to Evaluate Ad35-GRIN/ENV HIV Vaccine in Healthy Adult Volunteers
A Phase I Placebo-controlled, Double-blinded (in Terms of Vaccine or Placebo), Randomized Dose-escalation Trial to Evaluate the Safety and Immunogenicity of Ad35-GRIN/ENV HIV Vaccine in Healthy Adult Volunteers. (IAVI B001)
1 other identifier
interventional
56
1 country
1
Brief Summary
The purpose of this study is to evaluate the safety and immunogenicity of Ad35-GRIN/ENV HIV vaccine and Ad35-GRIN HIV vaccine administered intramuscularly at 0 and 6 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 hiv
Started Mar 2009
Typical duration for phase_1 hiv
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 24, 2009
CompletedFirst Posted
Study publicly available on registry
February 25, 2009
CompletedStudy Start
First participant enrolled
March 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedApril 25, 2012
April 1, 2012
2.4 years
February 24, 2009
April 23, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety (local and systemic reactogenicity signs and symptoms, laboratory measures, and adverse events)
18 months
Secondary Outcomes (1)
Immunogenicity: Proportion of volunteers with HIV-1 specific T-cell responses by ELISPOT assay.
18 months
Study Arms (4)
Group A
EXPERIMENTALAd35-GRIN/ENV: 2x10\^9 vp
Group B
EXPERIMENTALAd35-GRIN/ENV: 2x10\^10 vp
Group C
EXPERIMENTALAd35-GRIN/ENV: 2x10\^11 vp
Group D
EXPERIMENTALAd35-GRIN at 1x10\^10 vp
Interventions
This is a dose-escalation trial. Each group will receive the Ad35-GRIN/ENV vaccine at different dosage levels.
This is a dose-escalation trial. Group D will receive the Ad35-GRIN vaccine.
Eligibility Criteria
You may qualify if:
- Healthy males and females, as assessed by a medical history, physical exam, and laboratory tests
- Willing to comply with the protocol and follow up for the planned duration of the study (screening plus 18 months)
- In the opinion of the PI or designee, has understood the information provided. Written informed consent needs to be given before any study-related procedures are performed
- Amenable to HIV risk reduction counseling, committed to maintaining behavior consistent with low risk of HIV exposure through the last required visit, and willing to continue 5 yrs of annual follow-up contact
- Demonstrates understanding (assessment of understanding will be performed) of the risk for harm observed in the STEP Study results
- Assessed by the clinic staff as being at "low risk" for HIV infection on the basis of sexual behaviors within the 12 months prior to enrolment defined as follows:
- Sexually abstinent OR
- Had two or fewer mutually monogamous relationships with partners believed to be HIV-uninfected and who did not use illicit drugs ( methamphetamines (crystal meth), heroin, cocaine, including crack cocaine or chronic marijuana abuse) OR
- Had two or fewer partners believed to be HIV-uninfected and who did not use illicit drugs (methamphetamines (crystal meth), heroin, cocaine, including crack cocaine or chronic marijuana abuse), and with whom he/she regularly used condoms for vaginal and anal intercourse
- Willing to undergo HIV Testing, HIV counseling and receive HIV Test results
- If sexually active female, using an effective method of contraception (hormonal contraceptive; diaphragm; Intra Uterine Device (IUD); condoms; anatomical sterility in self or partner) from screening until at least 4 months after last vaccination. All female volunteers must be willing to undergo urine pregnancy tests at time points as indicated in the Schedule of Procedures
- If sexually active male, willing to use an effective method of contraception (such as condoms, anatomical sterility) from screening until 4 months after the last vaccination
You may not qualify if:
- Confirmed HIV-1 or HIV-2 infection
- Detection of Ad35-specific serum neutralizing antibody
- Reported high-risk behavior for HIV infection defined as:
- Within 12 months before vaccination, the volunteer has:
- Had unprotected vaginal or anal sex with a known HIV infected person or a casual partner (i.e. no continuing established relationship)
- Engaged in sex work for money or drugs.
- Excessive daily alcohol use or frequent binge drinking or chronic marijuana use or use of other illicit drugs.
- Recently acquired a sexually transmitted disease (STD) including syphilis, gonorrhoea, non-gonococcal urethritis, Trichomonas vaginalis, symptomatic Herpes genitalis (HSV-2), chlamydia, pelvic inflammatory disease (PID), mucopurulent cervicitis, epididymitis, proctitis, lymphogranuloma venereum, chancroid, or hepatitis B).
- Has a high-risk partner either currently or had such a partner within the previous 12 months.
- Any clinically significant abnormality on history or examination, including history of immunodeficiency or autoimmune disease; use of systemic corticosteroids (the use of topical steroids and inhaled steroids for sinus decongestion are permitted), immunosuppressive, antiviral, 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, would make the volunteer unsuitable for the study.
- Any of the following abnormal laboratory parameters
- Hemoglobin \<11.0 g/dL for women and \<12.5 g/dL for men
- Absolute Neutrophil Count (ANL): ≤ 999/mm3
- Absolute Lymphocyte Count (ALC): ≤ 500/mm3
- +18 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- International AIDS Vaccine Initiativelead
- University of Rochestercollaborator
Study Sites (1)
University of Rochester Medical Center
Rochester, New York, 14642, United States
Related Publications (1)
Keefer MC, Gilmour J, Hayes P, Gill D, Kopycinski J, Cheeseman H, Cashin-Cox M, Naarding M, Clark L, Fernandez N, Bunce CA, Hay CM, Welsh S, Komaroff W, Hachaambwa L, Tarragona-Fiol T, Sayeed E, Zachariah D, Ackland J, Loughran K, Barin B, Cormier E, Cox JH, Fast P, Excler JL. A phase I double blind, placebo-controlled, randomized study of a multigenic HIV-1 adenovirus subtype 35 vector vaccine in healthy uninfected adults. PLoS One. 2012;7(8):e41936. doi: 10.1371/journal.pone.0041936. Epub 2012 Aug 3.
PMID: 22870265DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Keefer
University of Rochester
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
February 24, 2009
First Posted
February 25, 2009
Study Start
March 1, 2009
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
April 25, 2012
Record last verified: 2012-04