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Lack of developmental neurotoxicity of MN rgp 120/HIV-1 administered subcutaneously to neonatal rats
J L Bussiere1, L M Hardy, M Peterson
1Department of Toxicology, Genentech, Inc., South San Francisco, CA 94080, USA. bussiere@gene.com
Insights
This study found that the recombinant subunit vaccine of gp120 from HIV-1 (MN rgp120/HIV-1) did not cause neurotoxicity or developmental toxicity in neonatal rats. Exposure during gestation and the neonatal period showed no adverse effects on development or neurobehavior.
Area of Science:
- Neuroscience
- Toxicology
- Vaccinology
Background:
- Assessing vaccine safety is crucial for public health.
- Neurodevelopmental toxicity is a key concern for vaccines administered during pregnancy or to neonates.
Purpose of the Study:
- To evaluate the potential neurotoxic and developmental effects of a recombinant gp120 subunit vaccine from HIV-1 (MN rgp120/HIV-1) in rat offspring.
- To determine if prenatal and/or neonatal exposure to MN rgp120/HIV-1, with or without adjuvants, impacts neurobehavioral and physical development.
Main Methods:
- Pregnant rats were exposed to MN rgp120/HIV-1 with alum adjuvant or vehicle during gestation.
- Offspring received daily injections of MN rgp120/HIV-1 (with or without alum or QS-21 adjuvant) or vehicle from postnatal day 1 to 22.
- Comprehensive neurobehavioral tests, physical development assessments, and neuropathological examinations were conducted.
Main Results:
- No persistent adverse effects were observed in any neurobehavioral or physical development parameters evaluated in the offspring.
- Neurohistological examination revealed no treatment-related pathological findings in the brain.
- Administration of MN rgp120/HIV-1, with or without adjuvant, did not induce neurotoxicity or developmental toxicity.
Conclusions:
- The MN rgp120/HIV-1 vaccine, alone or formulated with alum or QS-21 adjuvant, is not neurotoxic or developmentally toxic in neonatal rats.
- These findings support the safety profile of this HIV-1 vaccine candidate concerning neurodevelopmental endpoints.
Abstract:
The potential for neurotoxic effects was evaluated in rat off-spring after exposure in utero and/or during the neonatal period to a recombinant subunit vaccine of gp120 prepared from the MN strain of HIV-1 (MN rgp 120/HIV-1). Thirty pregnant female rats were given MN rgp120/HIV-1 with alum adjuvant, and 30 rats were given vehicle, once every 3 days from Day 1 of presumed gestation until parturition. One pup/sex/litter from treated and control group dams were given a daily subcutaneous injection, from Day 1 through Day 22 postpartum (PP) of vehicle, MN rgp120/HIV-1, MN rgp120/HIV-1 with alum, or MN rgp120/HIV-1 with QS-21 adjuvant. Neurobehavioral and physical development were evaluated (preweaning reflex and development, sexual maturation, motor activity, acoustic startle, passive avoidance, functional observational battery, and water M-maze testing), and tissues were processed for anatomical examination (whole and regional brain weights, and neuropathology). Administration of MN rgp120/HIV-1, with or without adjuvant, to pups did not cause any persistent effect on any parameter evaluated. Neurohistological examination did not reveal any pathological effects related to treatment. Thus, MN rgp120/HIV-1 alone or formulated as a vaccine does not cause neurotoxicity or developmental toxicity in neonatal rats after exposure in utero and/or during the neonatal period.
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