A Trial to Evaluate Ad35-GRIN/ENV HIV Vaccine in Healthy Adult Volunteers

Completed · Phase 1

Conditions studied: HIV, HIV Infections

In brief

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.

Key facts

Study ID

NCT00851383

Run by

International AIDS Vaccine Initiative

People needed

56

Starts

2009-03-01

Expected to finish

2011-08-01

Last updated by the study team

2012-04-25

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

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
• Platelets: ≤ 90,000 ≥ 550,000/mm3
• Creatinine: >1.1 ULN
• AST: >1.25 x ULN
• ALT: >1.25 x ULN
• Urinalysis 2+ by urine dipstick
• Blood (not due to menses);
• Protein
• Leucocytes
• Confirmed diagnosis of hepatitis B (surface antigen HbsAg), hepatitis C (HCV antibodies), or active syphilis
• If female, pregnant or planning a pregnancy within 4 months after last vaccination; or lactating

Where it is running

• University of Rochester Medical Center — Rochester, New York, United States

Full record on ClinicalTrials.gov

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