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HIVPhase 1NCT00851383

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

A Phase 1 study testing Ad35-GRIN/ENV and Ad35-GRIN in people with HIV and HIV Infections, run by International AIDS Vaccine Initiative at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
HIV, HIV Infections
What is being tested?
Ad35-GRIN/ENV and Ad35-GRIN
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteUnited States
Study dates
Mar 2009to Aug 2011
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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:
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  • 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

Who cannot join

  • 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.
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  • 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
  • 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 within the previous 14 days or planned receipt within 14 days after vaccination with Investigational Product
  • Receipt of blood transfusion or blood products within the previous 6 months
  • Participation in another clinical study of an investigational product currently, within the previous 3 months or expected participation during this study
  • Receipt of another investigational HIV vaccine candidate at any time
  • History of severe or very severe local or systemic reactogenicity to vaccines or history of severe allergic reactions
  • Major psychiatric illness, including any history of schizophrenia or severe psychosis, bipolar disorder requiring therapy, suicidal attempt or ideation in the previous 3 yrs
  • Unwilling to forgo donations of blood, sperm, eggs, bone marrow or organs during the study
  • Asplenia: any condition resulting in the absence of a spleen

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Rochester Medical Center

    Rochester, New York, 14642

Other trials in United States

About this study

Official title: 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)

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.

Read the detailed description

This study is a phase I dose-escalation randomized, placebo-controlled study designed to evaluate the safety and immunogenicity of Ad35-GRIN and Ad35-ENV filled in the same vial and administered as a single, combined vaccine. This is the first administration of this vaccine in humans. The study will be double blind with respect to vaccine or placebo. The vaccine will be administered intramuscularly at months 0 and 6 at three dose levels: 2 x 10^9, 2 x 10^10, and 2 x 10^11 vp per dose. Volunteers will be randomized to vaccine: placebo in a 10:4 ratio in each group. A fourth group was added as a protocol amendment to study Ad35-GRIN HIV vaccine alone at 1x10^10 vp in 14 volunteers (10:4 vaccine:placebo).

Volunteers will be screened up to 42 days before vaccination (90 days for Ad35 neutralizing antibody screening) and will be followed for 12 months after the last vaccination (18 months total study participation). Estimated enrollment will take approximately 5 months. Thus, the total duration of the study would be approximately 23 months.

Conditions
HIV, HIV Infections
Being tested
Ad35-GRIN/ENV, Ad35-GRIN
Keywords
HIV, Human Immunodeficiency Virus, HIV Seronegativity, Preventive Vaccine
Medical subject headings
HIV Infections, Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ad35-GRIN/ENVBiological

    This is a dose-escalation trial. Each group will receive the Ad35-GRIN/ENV vaccine at different dosage levels.

  • Ad35-GRINBiological

    This is a dose-escalation trial. Group D will receive the Ad35-GRIN vaccine.

Study groups in NCT00851383
Study groupRoleWhat they receive
Group AExperimentalAd35-GRIN/ENV: 2x10^9 vp
Receives: Biological: Ad35-GRIN/ENV
Group BExperimentalAd35-GRIN/ENV: 2x10^10 vp
Receives: Biological: Ad35-GRIN/ENV
Group CExperimentalAd35-GRIN/ENV: 2x10^11 vp
Receives: Biological: Ad35-GRIN/ENV
Group DExperimentalAd35-GRIN at 1x10^10 vp
Receives: Biological: Ad35-GRIN

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety (local and systemic reactogenicity signs and symptoms, laboratory measures, and adverse events)

    Measured: 18 months

Secondary outcomes (1)

  1. Immunogenicity: Proportion of volunteers with HIV-1 specific T-cell responses by ELISPOT assay.

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2009 (estimated)
  2. Study startMar 2009
  3. Primary completionAug 2011
  4. Study completionAug 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00851383
Sponsor's protocol ID
IAVI B001
Status last verified
Apr 2012
First submitted
24 Feb 2009
Last updated
25 Apr 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 22870265

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ad35-GRIN/ENV and Ad35-GRIN in people with HIV and HIV Infections, run by International AIDS Vaccine Initiative at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety (local and systemic reactogenicity signs and symptoms, laboratory measures, and adverse events) (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00851383, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2012.

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