Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Experiment Videos

Remune. Immune Response.

Derhsing Lai1, Taff Jones

  • 1Vincogen Corp, Yardley, PA 19067, USA. derhsing@prodigy.net

Current Opinion in Investigational Drugs (London, England : 2000)
|June 11, 2002
PubMed
Summary
This summary is machine-generated.

Related Concept Videos

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

The role of nasal IgA in children vaccinated with live attenuated influenza vaccine.

Vaccine·2012
Same author

Safety and immunogenicity following administration of a live, attenuated monovalent 2009 H1N1 influenza vaccine to children and adults in two randomized controlled trials.

PloS one·2010
Same author

Vacc-4x, a therapeutic vaccine comprised of four engineered peptides for the potential treatment of HIV infection.

Current opinion in investigational drugs (London, England : 2000)·2010
Same author

GSK's novel split-virus adjuvanted vaccines for the prevention of the H5N1 strain of avian influenza infection.

Current opinion in molecular therapeutics·2009
Same author

IC-51, an injectable vaccine for the prevention of Japanese encephalitis virus infection.

Current opinion in molecular therapeutics·2009
Same author

IMVAMUNE, an attenuated modified vaccinia Ankara virus vaccine for smallpox infection.

Current opinion in molecular therapeutics·2008

Remune, a therapeutic vaccine for HIV, showed potential in early trials but faced setbacks in Phase III studies. Despite regulatory challenges and discontinued development by partners, manufacturing facility compliance was achieved in Thailand.

Area of Science:

  • Immunology and Virology
  • Therapeutic Vaccine Development

Background:

  • The Immune Response Corp (IRC) developed Remune, a therapeutic vaccine candidate for HIV.
  • Remune is based on the Salk Immunogen, derived from inactivated HIV with depleted glycoprotein 120 (gp120).

Purpose of the Study:

  • To evaluate the efficacy of Remune as a therapeutic vaccine for HIV, particularly in combination with antiviral therapy.
  • To assess the potential for achieving undetectable levels of HIV in patients undergoing treatment.

Main Methods:

  • Initiation of a large-scale, multicenter, double-blind, pivotal Phase III study (Study 806) involving 2500 patients.
  • Subsequent initiation of two additional Phase III surrogate marker trials following interim analysis.
  • Regulatory filings and manufacturing facility inspections, including GMP compliance certification in Thailand.

Related Experiment Videos

Main Results:

  • Preliminary data suggested Remune, combined with antiviral therapy, could lead to undetectable HIV levels.
  • Interim analysis of the pivotal Phase III study led to its conclusion, prompting a shift in regulatory strategy.
  • Despite development challenges and partner withdrawals, the Remune manufacturing facility in Thailand achieved GMP compliance.

Conclusions:

  • Remune demonstrated early promise as an HIV therapeutic vaccine but encountered significant challenges in late-stage clinical development.
  • The development path involved complex regulatory strategies and partnerships, with varying outcomes across different markets.
  • The Thai FDA's certification of the manufacturing facility represented a key regulatory milestone for potential market entry in Thailand.