APSV in Vaccinia Naive Adults

Status Completed

Clinical Trial Summary

The study seeks to define, with precision, the safety and efficacy of APSV, two dose potencies of one lot in vaccinia-naive adults. The ability of this vaccine to induce a classic �take� as defined by formation of a lesion at the injection site consistent with the �Jennerian� process (see Appendix A) and vaccine specific immune responses will be assessed. The local cutaneous lesion is considered to be a surrogate for clinical effectiveness of live, replicating smallpox vaccines. Neutralizing antibody formation has been correlated with takes for the Dryvax vaccine and is considered to be cross-protective for other orthopoxviruses, including variola. The study also seeks to characterize preliminarily the cell mediated immune (CMI) response to APSV (as compared to Dryvax).

Clinical Trial Description

A Multicenter, double blind, randomized trial in which each volunteer will receive one of 2 dose concentrations of one of two lots of Aventis Pasteur Smallpox Vaccine as a single vaccination (undiluted, 1:5 dilution). Volunteers without a take at day 7 - 9 will be offered a vaccination with Dryvax at the end of the study. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Primary Purpose: Prevention

Related Conditions & MeSH terms

Smallpox

Clinical Trial Details

NCT number	NCT00050518
Study type	Interventional
Source	National Institute of Allergy and Infectious Diseases (NIAID)
Contact
Status	Completed
Phase	Phase 2
Completion date	February 2003

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05976100` - Study of the Safety, Tolerability, Pharmacokinetics of NIOCH-14 in Volunteers Aged 18-50 Years	Phase 1
Completed	`NCT01540929` - Post-licensure Department of Defense (DOD) Screening Accuracy Study in Military Personnel
Completed	`NCT00258947` - Evaluation of Take and Safety of a Smallpox Vaccine in Healthy Young Adults	Phase 2
Completed	`NCT00189969` - Take Rate, Immunogenicity and Safety of Elstree-BN Smallpox Vaccine in Healthy Vaccinia-Naive Subjects	Phase 1
Terminated	`NCT00053508` - Dose Safety, Tolerability, and Immunogenicity of a New Smallpox Vaccine in Adults Without Previous Smallpox Vaccination	Phase 2
Completed	`NCT01317238` - Safety and Efficacy of CJ Smallpox Vaccine in Previously Vaccinated Healthy Volunteers	Phase 3
Completed	`NCT01056770` - Safety and Efficacy of CJ Smallpox Vaccine in Healthy Volunteers	Phase 3
Completed	`NCT00998543` - A Long-Term Study of Healthy Adults Vaccinated With One Dose of Smallpox Vaccine (LISTER Strain)	Phase 2
Withdrawn	`NCT00389103` - Safety Study of MVA Smallpox Vaccine in Subjects With a History of Atopic Dermatitis (AD)	Phase 1
Terminated	`NCT00282581` - Safety Study of MVA Smallpox Vaccine in HIV-positive Subjects Who Are Vaccinia Naive	Phase 1
Completed	`NCT00133575` - ACAM 3000 MVA at Harvard Medical School	Phase 1/Phase 2
Active, not recruiting	`NCT00103584` - Safety and Immunogenicity Study of LC16m8, a Modified Smallpox Vaccine, in Healthy, Previously Unvaccinated Volunteers	Phase 1/Phase 2
Completed	`NCT00050505` - Expanded Dryvax Dilution Study in Previously Vaccinated Adults	Phase 2
Completed	`NCT05846243` - Study on Immunogenicity, Reactogenicity and Safety of the VACΔ6 Vaccine in Volunteers Aged 18-60 Years	Phase 2/Phase 3
Completed	`NCT05935917` - Study Evaluating the Bioequivalence of Brincidofovir Form H and Form II Tablets in Healthy Adults	Phase 1
Completed	`NCT00082446` - Combination Study With MVA BN and Dryvax	Phase 1
Completed	`NCT00038987` - Vaccinia Virus Vaccine (APSV) in Vaccinia- Naive Subjects: PILOT	Phase 1/Phase 2
Completed	`NCT05762523` - Safety and Tolerability Study of the VAC∆6 Vaccine in Volunteers Aged 18-40 Years	Phase 1
Completed	`NCT04971109` - Safety, Tolerability and Pharmacokinetics of TPOXX When Administered Orally for 28 Day	Phase 3
Completed	`NCT00646152` - Poly-ICLC to Prevent Respiratory Viral Infections A Safety Study	Phase 1