Status:
COMPLETED
Vaccine Treatment for HIV-Infection
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Healthy
Eligibility:
All Genders
20-37 years
Phase:
PHASE1
Brief Summary
This study will determine the safety and side effects of an experimental adenoviral vector vaccine given to patients who previously received a different HIV vaccine (VRC-HIVDNA016-00-VP) in a prior NI...
Detailed Description
Study Design: This is a Phase I open-label study to examine safety, tolerability and immune response of a multiclade HIV adenoviral vector vaccine as a booster vaccination in uninfected adults. The hy...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- A participant must meet all of the following criteria:
- Enrolled into VRC 007 no more than 36 weeks prior to VRC 010 enrollment and completed three injections of 4 mg of study vaccine in VRC 007 (04-I-0254) without experiencing a serious adverse event (SAE) that was possibly, probably or definitely related to study vaccine.
- Available for clinical follow-up for 24 weeks after enrollment into VRC 010.
- Completion of an Assessment of Understanding prior to enrollment and able to verbalize understanding of all questions answered incorrectly.
- Able and willing to complete the informed consent process.
- Willing to receive HIV test results and willing to abide by NIH guidelines for partner notification of positive HIV results.
- Willing to donate blood for sample storage to be used for future research.
- Willing to discuss HIV infection risks and amenable to risk reduction counseling.
- In good general health without clinically significant medical history and satisfactory completion of the screening process.
- Laboratory Criteria within 28 days prior to enrollment:
- Hemoglobin greater than or equal to 11.5 g/dL for women; greater than or equal to13.5 g/dL for men;
- WBC = 3,300-12,000 cells/mm(3);
- Differential either within institutional normal range or accompanied by site physician approval;
- Total lymphocyte count greater than or equal to 800 cells/mm(3);
- Platelets = 125,000 - 550,000/mm(3);
- ALT (SGPT) less than or equal to 1.25 x upper limit of normal;
- Serum creatinine less than or equal to 1 x upper limit of normal (less than or equal to 1.3 mg/dL for females; less than or equal to 1.4 mg/dL for males);
- Normal urinalysis defined as negative glucose, negative or trace protein, and no clinically significant blood in the urine;
- Negative HIV PCR (i.e., less than the lower limit of detection or less than 50 RNA copies/mL);
- Negative Hepatitis B surface antigen;
- Negative anti-HCV (hepatitis C virus antibody) and negative HCV PCR.
- Female-Specific Criteria:
- Negative beta-HCG pregnancy test (urine) on day of study enrollment for women presumed to be of reproductive potential.
- A female participant must meet one of the following criteria:
- No reproductive potential because of menopause \[one year without menses\] or because of a hysterectomy, bilateral oophorectomy, or tubal ligation,
- or
- Participant agrees to be heterosexually inactive at least 21 days prior to enrollment and through Week 24 of the study,
- or
- Participant agrees to consistently practice contraception at least 21 days prior to enrollment and through Week 24 of the study by one of the following methods:
- condoms, male or female, with or without a spermicide;
- diaphragm or cervical cap with spermicide;
- intrauterine device;
- contraceptive pills or patch, Norplant, Depo-Provera or other FDA-approved contraceptive method;
- male partner has previously undergone a vasectomy for which there is documentation.
- EXCLUSION CRITERIA:
- A volunteer will be excluded if one or more of the following conditions apply:
- Women:
- Breast-feeding or planning to become pregnant during the 24 weeks of study participation.
- Volunteer has received any of the following substances:
- Immunosuppressive or cytotoxic medications or inhaled corticosteroids within the past six months (with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis).
- Blood products within 120 days prior to HIV screening.
- Immunoglobulin within 60 days prior to HIV screening.
- Live attenuated vaccines within 30 days prior to initial study vaccine administration.
- Investigational research agents within 30 days prior to study vaccine administration.
- Medically indicated subunit or killed vaccines, e.g. influenza, pneumococcal, or allergy treatment with antigen injections, within 14 days of study vaccine administration.
- Current anti-TB prophylaxis or therapy.
- Volunteer has a history of any of the following clinically significant conditions:
- Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain.
- Autoimmune disease or immunodeficiency.
- Asthma that is unstable or required emergent care, urgent care, hospitalization or intubation during the past two years or that requires the use of oral or intravenous corticosteroids.
- Diabetes mellitus (type I or II), with the exception of gestational diabetes.
- History of thyroidectomy or thyroid disease that required medication within the past 12 months.
- Serious angioedema episodes within the previous 3 years or requiring medication in the previous two years.
- Hypertension that is not well-controlled by medication or is more than 145/95 at enrollment.
- Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws.
- Syphilis infection that is active or a positive serology due to a syphilis infection treated less than six months ago.
- Malignancy that is active or treated malignancy for which there is not reasonable assurance of sustained cure or malignancy that is likely to recur during the period of the study.
- Seizure disorder other than: 1) febrile seizures under the age of two, 2) seizures secondary to alcohol withdrawal more than 3 years ago, or 3) a singular seizure not requiring treatment within the last 3 years.
- Asplenia or any condition resulting in the absence or removal of the spleen.
- Psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder; disorder requiring lithium; or within five years prior to enrollment, history of a suicide plan or attempt.
- Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent.
Exclusion
Key Trial Info
Start Date :
April 13 2005
Trial Type :
INTERVENTIONAL
End Date :
January 15 2008
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00108654
Start Date
April 13 2005
End Date
January 15 2008
Last Update
July 2 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892