Status:
COMPLETED
Safety of and Immune Response to an Adenoviral HIV-1 Vaccine in Healthy Adults
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
Successful control of the HIV epidemic will require a safe and effective vaccine to be developed. A successful vaccine will need to stimulate a widespread immune response. The purpose of this study is...
Detailed Description
HIV infection continues to spread at pandemic levels throughout the world. Control of this pandemic can only be achieved with the development of a safe and effective preventive HIV vaccine. A vaccine ...
Eligibility Criteria
Inclusion
- Good general health with normal hematological, hepatic and renal functions
- Demonstrated understanding of study
- Willing to receive HIV test results
- HIV-1 and -2 uninfected
- Hepatitis B surface antigen negative
- Anti-hepatitis C virus (anti-HCV) negative antibody or negative HCV PCR if anti-HCV is positive
- Appropriate hemoglobin, white blood cell, lymphocyte, and platelet count values as defined in the study protocol
- Certain laboratory values as defined in the study protocol
- Adequate contraception from at least 21 days prior to study entry through visit 10
Exclusion
- HIV vaccines or placebos in prior HIV vaccine trial
- Immunosuppressive medications within 168 days prior to first injection. Participants taking corticosteroid nasal spray or topical corticosteroids are not excluded.
- Blood products within 120 days prior to first injection
- Immunoglobulin within 60 days prior to first injection
- Investigational agents within 30 days prior to first injections
- Live attenuated vaccine within 30 days prior to first injection
- Any vaccine not a live attenuated vaccine within 14 days prior to first injection
- Any clinically significant medical condition that, in the opinion of the investigator, may interfere with the study
- Any medical, psychiatric, occupational, or social condition or responsibility that, in the opinion of the investigator, would interfere with the study
- Serious adverse reaction to vaccines. Participants who had a nonanaphylactic adverse reaction to pertussis vaccine as a child are not excluded.
- Known autoimmune disease
- Known immunodeficiency
- Asthma other than mild and/or well-controlled asthma
- Active syphilis infection. Those fully treated for syphilis over 6 months prior to study entry are not excluded.
- Diabetes mellitus type 1 or 2
- Thyroidectomy or thyroid disease requiring medication within 12 months prior to study entry
- Angioedema in the 3 years prior to study entry if the episodes are considered serious or have required medication within the last 2 years
- Hypertension. More information on this criterion can be found in the protocol.
- Body mass index (BMI) of 40 or higher OR BMI of 35 or greater, if other cardiovascular risk factors. More information on this criterion can be found in the protocol.
- Bleeding disorder
- Malignancy, unless it has been surgically removed and, in the opinion of the investigator, is not likely to recur during the study period
- Seizure disorder or occurrence of seizure in the 3 years prior to study entry. Participants who have not required medications or had a seizure for prior 3 years are not excluded.
- Absence of a functional spleen
- Psychiatric condition within the last 3 years. More information on this criterion can be found in the study protocol.
- Individuals at high-risk of acquiring HIV infection
- Presence of pre-existing neutralizing antibodies for Adenovirus 26
- Pregnancy or breastfeeding
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00618605
Start Date
February 1 2008
End Date
October 1 2015
Last Update
November 1 2021
Active Locations (1)
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1
Brigham and Women's Hosp. Novel Adenoviral Vector Prophylactic HIV Vaccine Non-Network CRS
Boston, Massachusetts, United States, 02115-6110