Completed
GENEVAX-HBV Vaccine: Intramuscular or Intradermal Administration in HIV Seronegative Volunteers
What is being tested
APL 400-003
Biological
Who is being recruted
Blood-Borne Infections+11
+ Urogenital Diseases
+ Genital Diseases
From 18 to 60 Years
+26 Eligibility Criteria
How is the trial designed
Prevention Study
Phase 1
Interventional
Summary
Principal SponsorWyeth-Lederle Vaccines
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
Volunteers receive either intradermal or intramuscular injections of GENEVAX-HIV; humoral and cellular responses are assessed accordingly.
Principal SponsorWyeth-Lederle Vaccines
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Prevention Study
Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 60 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsHIV Infections
Criteria
9 inclusion criteria required to participate
Ability to understand the basis of HIV transmission and other common sexual and blood-borne infections
Endocrine/Metabolic: Serum calcium, serum glucose, total serum CPK within normal range
Good health
Hematopoietic: total white blood cell, lymphocyte, granulocyte, and platelet count, hemoglobin and hematocrit within normal range
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17 exclusion criteria prevent from participating
Active drug or alcohol abuse or uncontrolled (unstable) psychiatric disorders which, in the opinion of the investigator, would interfere with study participation
Any condition which, in the opinion of the principal investigator, might interfere with completion of the study or evaluation of the results
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
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
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Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Walter Reed Army Institute of Research
Washington D.C., United StatesOpen Walter Reed Army Institute of Research in Google MapsCompletedOne Study Center