Safety and Immunogenicity Study of 2 Investigational Preventive HIV Vaccines
This study has been completed.
Sponsor:
International AIDS Vaccine Initiative
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
International AIDS Vaccine Initiative
ClinicalTrials.gov Identifier:
NCT01264445
First received: December 20, 2010
Last updated: February 8, 2013
Last verified: February 2013
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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.
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Biological: Adjuvanted GSK investigational HIV vaccine formulation 1 Biological: Adjuvanted GSK investigational HIV vaccine formulation 2 Biological: Ad35 investigational HIV vaccine Biological: Placebo (saline) |
Phase 1 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
Official Title: | A Phase I Double-blinded, Placebo-controlled, Randomized Trial in HIV-uninfected, Healthy Adult Volunteers to Evaluate the Safety and Immunogenicity of an Adjuvanted GSK HIV Vaccine Administered With Ad35-GRIN Investigational Vaccine |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
Further study details as provided by International AIDS Vaccine Initiative:
Primary Outcome Measures:
- Safety of an adjuvanted HIV protein vaccine in prime-boost combinations with AD35-GRIN or coadministered with AD35-GRIN [ Time Frame: 16 months ] [ Designated as safety issue: Yes ]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
Secondary Outcome Measures:
- Immunogenicity of an adjuvanted HIV protein vaccine given in different prime-boost regimens with Ad35-GRIN or coadminisitered with Ad35-GRIN [ Time Frame: 16 months ] [ Designated as safety issue: No ]
Enrollment: | 147 |
Study Start Date: | February 2011 |
Study Completion Date: | November 2012 |
Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Experimental: Group A
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
Receive at Months 0 and 1
Biological: Ad35 investigational HIV vaccine
Receive at Month 4
Biological: Placebo (saline)
(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.)
|
Experimental: Group B
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
Receive at Months 0 and 1
Biological: Ad35 investigational HIV vaccine
Receive at Month 4
Biological: Placebo (saline)
(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.)
|
Experimental: Group C
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
Receive at Month 0
Biological: Adjuvanted GSK investigational HIV vaccine formulation 2
Receive at Months 3 and 4
Biological: Placebo (saline)
(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.)
|
Experimental: Group D
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
Receive at Months 0, 1, and 4
Biological: Ad35 investigational HIV vaccine
Receive at Months 0, 1, and 4
Biological: Placebo (saline)
(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.)
|
Detailed Description:
Volunteers will be screened up to 42 days before vaccination (up to 90 days for Ad35 neutralizing antibody) and will be followed for 12 months after the last vaccination (16 months total participation).
It is estimated that it will take approximately 5 months to complete enrolment.
![](https://webarchive.library.unt.edu/web/20130315212537im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Prior receipt of another investigational HIV vaccine candidate (note: receipt of an HIV vaccine placebo will not exclude a volunteer from participation if documentation is available and the IAVI Medical Monitor gives approval)
- History of severe local or systemic reactogenicity to vaccines (e.g. anaphylaxis, respiratory difficulty, angioedema)
- History of severe allergic reactions to any substance requiring hospitalization or emergency medical care (e.g. Steven-Johnson syndrome, bronchospasm or hypotension)
- Known sensitivity to sulphite, aspirin or aminoglycoside antibiotics (e.g. amikacin, arbekacin, gentamicin, kanamycin, neomycin, netilmicin, paromomycin, streptomycin, tobramycin, etc)
- Confirmed diagnosis of active hepatitis B (HBsAg), hepatitis C (HCV antibodies), active syphilis or active tuberculosis
- History of severe neurological disorder, seizure or psychiatric disorder (e.g schizophrenia, severe psychosis, bipolar disorder requiring therapy, suicidal attempt or ideation)
- For those volunteers at clinical centres participating in ophthalmic examinations, any clinically significant abnormality found on baseline ophthalmic examination.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01264445
Locations
Kenya | |
Kenya AIDS Vaccine Initiative | |
Nairobi, Kenya | |
Uganda | |
Uganda Virus Research Institute-IAVI | |
Entebbe, Uganda | |
Medical Research Council | |
Masaka, Uganda | |
Zambia | |
Zambia-Emory HIV Research Project | |
Lusaka, Zambia |
Sponsors and Collaborators
International AIDS Vaccine Initiative
GlaxoSmithKline
Investigators
Principal Investigator: | 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 |
![](https://webarchive.library.unt.edu/web/20130315212537im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Additional Information:
No publications provided
Responsible Party: | International AIDS Vaccine Initiative |
ClinicalTrials.gov Identifier: | NCT01264445 History of Changes |
Other Study ID Numbers: | IAVI B002 |
Study First Received: | December 20, 2010 |
Last Updated: | February 8, 2013 |
Health Authority: | United States: Food and Drug Administration Uganda: Uganda Virus Research Institute, Science and Ethics Committee (UVRI SEC) Uganda: National Drug Authority Uganda: Pharmacy and Poisons Board Kenya: Kenyatta National Hospital/University of Nairobi Ethics and Research Committee Kenya: National Council for Science and Technology (NCST) Zambia: University of Zambia Biomedical Research Ethics Committee (UNZAREC) Zambia: Emory Institutional Review Board Zambia: Pharmacy Regulatory Authority Zambia: Ministry of Health |
Keywords provided by International AIDS Vaccine Initiative:
HIV |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on March 14, 2013