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Preparation and characterization of human HIV type 1 neutralizing reference sera
1Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20852-1448, USA.
AIDS Research and Human Retroviruses
|July 1, 1995
Summary
Reference neutralizing antibody reagents are crucial for monitoring HIV-1 vaccine recipients. Two HIV-1 positive serum pools demonstrated sufficient neutralizing activity for use as international reference standards.
Area of Science:
- Immunology
- Virology
- Biotechnology
Background:
- Standardized neutralizing antibody (NA) assays are essential for monitoring HIV-1 vaccine efficacy.
- Lack of reference reagents hinders comparability of NA assay results across laboratories.
Purpose of the Study:
- To establish and characterize reference neutralizing antibody reagents for HIV-1.
- To provide standardized sera for HIV-1 vaccine monitoring.
Main Methods:
- Pooling and lyophilization of sera from HIV-1 seropositive individuals with cross-reactive NA activity.
- Preparation of a negative control serum pool.
- Rigorous testing for uniformity, sterility, stability, and antibody presence.
- International collaborative study to assess reagent potency in multiple laboratories.
Main Results:
- Two distinct HIV-1 positive serum pools exhibited medium to high cross-reactive NA activity against diverse HIV-1 strains.
- Ampoules showed uniformity, sterility, and stability.
- International collaborative study indicated reasonable consistency between laboratories using the reference sera.
- Both sera demonstrated sufficient titers for use as reference reagents.
Conclusions:
- The developed reference sera are suitable for use in HIV-1 neutralization assays.
- These reagents will facilitate consistent and comparable monitoring of HIV-1 vaccine recipients.
- The reference sera are available through the WHO AIDS Reagent Project.