Study of Safety and Immunogenicity of HIV Vaccines in Healthy Volunteers
Completed · Phase 1
Conditions studied: Vaccine Response
In brief
Background: \- Vaccines create resistance to disease. This study tests experimental human immunodeficiency virus (HIV) vaccines that use an adenovirus as a transporter. Transporters may help vaccines stimulate an immune response against HIV. This means the body works to fight infection. Researchers want to see if different ways of giving the vaccines cause different immune responses. They also want to see if the vaccines adenovirus is contagious. Adenoviruses cause cold symptoms or mild eye infections. Participants cannot get HIV from these vaccines. But they can get the adenovirus, so their entire household and intimate contacts must participate. Objective: \- To test the safety of experimental HIV vaccines. Eligibility: \- Healthy adults 18-49 years old. Design: * Participants will be screened with medical history, physical exam, and blood and urine tests. * Participants will receive the vaccine 3 times over 6 months. Each time, they will have a physical exam and blood and urine tests. Samples will be taken from their nose, rectum, and cervix. * Some participants will receive the vaccine by swallowing 11 capsules with water. Clinic staff will observe them for 1 hour. * Some participants will receive the vaccine swabbed in their throat. They will get dose 1 at the hospital and stay there for 1 week. They will have medical tests and nose swabs. Doses 2 and 3 will not require a hospital stay. * Participants will have 7 follow-up visits over 6 months, with a physical exam and blood tests. Samples will be taken from their nose, throat, and rectum. * Household and intimate contacts will have 4 clinic visits over 8 months, with a physical exam and blood tests.
Key facts
- Study ID
- NCT01989533
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 62
- Starts
- 2013-11-19
- Expected to finish
- 2019-04-08
- Last updated by the study team
- 2019-12-17
Who can join
Age: 18 and older, up to 49. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- A participant (vaccinees, household contacts, and intimate contacts) will be excluded if they have the following:
- Any condition that, in the investigator s judgement, places the subject at undue risk by participating in the study.
- The following exclusion criterion applies to vaccinees and intimate contacts, but not to household contacts:
- History of any prior disease or therapy which would affect immune or pulmonary function.
- Prior malignancy, except curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
- History of radiation therapy or cytotoxic/cancer chemotherapy.
- History of diabetes mellitus.
- Immunodeficiency or autoimmune disease.
- Acute infection or a recent (within 6 months) history of chronic infection suggestive of immunodeficiency.
- Taking any medication which may affect immune function, except participants may be taking low doses of nonprescription strength NSAIDS (including e.g. ibuprofen or aspirin) or acetaminophen.
- Chronic respiratory disorders including asthma, emphysema, interstitial lung disease, pulmonary hypertension, recurrent pneumonia, or recent or ongoing respiratory tract infection. If a respiratory disorder is transient, defer immunization but do not exclude the participant.
- Active Hepatitis B or C infection (i.e. Hepatitis B or C positive serology with the presence of virus antigen or DNA. Ongoing viral replication will be confirmed by a Hepatitis B antigen or Hepatitis C viral load).
- Female of child-bearing potential who is breast-feeding or planning pregnancy during the 28 days following vaccination.
- The following exclusion criteria apply only to vaccinees and not to household or intimate contacts:
- Any medical, psychiatric, or social condition, or occupational or other responsibility that, in the judgment of the investigator, would interfere with or serve as a contraindication to receipt of live virus vaccine, protocol adherence, or a participant s ability to give informed consent.
- Psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder requiring therapy that has not been well controlled on medication for the past two years; disorder requiring lithium; or suicidal ideation occurring within five years prior to enrollment.
- Participants that live in the same house or apartment with any of the following will be excluded:
- An individual under 18 years of age.
- An elderly individual (>65 years of age).
- An immunocompromised or immunosuppressed individual.
- An individual with chronic respiratory disease.
- A woman who is currently pregnant or planning a pregnancy during the period of immunization.
- Healthcare worker who has direct contact with immunodeficient, unstable patients, or pediatric patients.
- Participants caring for children <18 years of age.
- Receipt of any of the following:
Where it is running
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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