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Immune response at birth, long-term immune memory and 2 years follow-up after in-utero anti-HBV DNA immunization

V M Fazio1, F Ria, E Franco

  • 1Interdisciplinary Center for Biomedical Research, Laboratory for Molecular Medicine and BioTechnology, Università 'Campus Bio-Medico', Rome, Italy.

Gene Therapy
|March 5, 2004
PubMed

Insights

In-utero DNA vaccination in pigs demonstrated protective antibody levels at birth, preventing early infant infections. Immune memory was established, showing long-term safety and potential for preventing neonatal mortality.

Area of Science:

  • Immunology
  • Vaccinology
  • Neonatal Health

Background:

  • Neonatal infections pose a significant threat to infant survival in the first week of life.
  • In-utero DNA immunization shows promise for inducing specific immunity in newborns.
  • Developing vaccines protective at birth is crucial for preventing early-life infections.

Purpose of the Study:

  • To evaluate the safety and efficacy of in-utero DNA vaccination in a large animal model suitable for human development.
  • To assess protection at delivery and the establishment of immune memory following in-utero immunization.
  • To determine the optimal timing for in-utero gene delivery to avoid immune tolerance.

Main Methods:

  • Single intramuscular in-utero immunization with anti-Hepatitis B Virus (HBV) DNA in pigs at two-thirds gestation.
  • Monitoring of antibody titers at birth and after recall immunizations at 4 and 10 months.
  • Short-term and long-term safety assessments, including monitoring fetus survival, local alterations, delivery, breastfeeding, and up to 2 years post-vaccination.

Main Results:

  • A single in-utero immunization induced protective anti-HBV antibody titers at birth.
  • Recall immunizations at 4 and 10 months confirmed the establishment of robust immune memory.
  • In-utero manipulation demonstrated short-term safety (no fetus loss, spontaneous delivery) and long-term safety (2-year monitoring).
  • Fetal treatment closer to delivery resulted in immune ignorance, not tolerance, highlighting the importance of timing.

Conclusions:

  • In-utero DNA vaccination is a safe and effective strategy for inducing protective immunity in newborns.
  • This approach holds significant potential for preventing life-threatening neonatal infections.
  • Naked DNA-based vaccination technology offers a promising therapeutic avenue for improving infant survival rates.

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