- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00002232
A Study of GENEVAX-HIV, a Possible Vaccine
GENEVAX-HIV (APL 400-003), a Candidate DNA Vaccine: A Pilot Study of GENEVAX-HIV Given by Intramuscular or Intradermal Administration in HIV Seronegative Volunteers
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
-
-
District of Columbia
-
Washington, District of Columbia, Forenede Stater, 20307
- Walter Reed Army Institute of Research
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria
Patients must have:
- Good health.
- Ability to understand the basis of HIV transmission and other common sexual and blood-borne infections.
- The following parameters within normal range:
- Hematopoietic:
- total white blood cell, lymphocyte, granulocyte, and platelet count, hemoglobin and hematocrit.
- Renal:
- BUN and creatinine, urinalysis.
- Hepatic:
- total serum bilirubin.
- Endocrine/Metabolic:
- Serum calcium, serum glucose, total serum CPK.
- Immunologic:
- total serum immunoglobulin and absolute CD4 count.
- Hepatitis B and Hepatitis C negative.
- Urinalysis:
- Normal screen with dipstick for esterase and nitrite.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
- HIV-seropositive status.
- Any positive result for anti-DNA antibodies considered of potential clinical significance as measured by anti-DNA antibody and/or anti-nuclear antibody (ANA) assays.
- Any condition which, in the opinion of the principal investigator, might interfere with completion of the study or evaluation of the results.
- Known hypersensitivity to bupivacaine or any amide-type local anesthetic (such as lidocaine, dibucaine, mepivacaine, and prilocaine) or a history of anaphylaxis or other serious adverse reactions to vaccines.
Concurrent Medication:
Excluded:
Any medication which may affect immune function with the exception of low doses of nonprescription-strength NSAIDS, aspirin, or acetaminophen for acute conditions such as headache or trauma.
Patients with the following prior conditions are excluded:
- HIV-seropositive.
- Known or suspected history of impairment or abnormality in immune functioning.
- Exposure to potentially-infective HIV fluids within the prior 6 months or tested positive for HIV at any time.
- History of any prior disease or therapy which would affect immune function including:
- Prior malignancy, except curatively-treated basal cell or squamous cell carcinoma in situ of the cervix.
- Immunodeficiency or autoimmune disease.
- Acute infection or a recent (within 6 months) history of chronic infection.
- History of serious allergic reaction to any substance requiring hospitalization or emergent medical care (e.g., Stevens-Johnson syndrome, bronchospasm, or hypotension).
Prior Medication:
Excluded:
Cytotoxic chemotherapy that may affect immune function.
Prior Treatment:
Excluded:
- Previous immunization with any experimental vaccines directed against HIV or receipt of any experimental agent within 30 days prior to enrollment.
- Receipt of any blood products or immunoglobulin within 6 months prior to enrollment.
- Exposure to live attenuated vaccines within 60 days of study.
- Radiotherapy that may affect immune function.
Risk Behavior:
Excluded:
- Active drug or alcohol abuse or uncontrolled (unstable) psychiatric disorders which, in the opinion of the investigator, would interfere with study participation.
- Higher- or intermediate-risk sexual behavior (AVEG criteria)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Maskning: Dobbelt
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: Merlin Robb
Datoer for undersøgelser
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 005
- 400-003-05
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