Vaccine efficacy against persistent HPV 16/18 infection at 10 years after one, two and three doses of quadrivalent HPV vaccine in girls in India
Ten years after vaccination, Indian girls who had received a single dose of HPV vaccine were as well protected against the cancer-causing HPV types as those who had two or three doses, which let the world switch to one-dose programmes.
Overview
Multicentre prospective cohort study arising from an IARC trial at nine Indian centres whose recruitment was suspended in 2010, leaving cohorts of girls aged 10 to 18 who had received one (4,949), two (4,980) or three (4,348) doses of quadrivalent HPV vaccine. At a median follow-up of 9.0 years (IQR 8.2-9.6), vaccine efficacy against persistent HPV 16/18 infection was 95.4% (95% CI 85.0-99.9) after one dose, 93.1% (77.3-99.8) after two and 93.3% (77.5-99.7) after three, compared with unvaccinated married women of similar age.
- Single-dose efficacy against persistent HPV 16/18 infection 95.4% at a median of 9 years.
- Two-dose 93.1% and three-dose 93.3%: no meaningful difference between schedules.
- Antibody levels after one dose were lower but stable over time.
- Cohorts were defined by default after the 2010 suspension, not by randomisation to one dose.
One dose protects. WHO endorsed one- or two-dose schedules in 2022, halving the cost and the logistics of vaccinating girls, which is decisive for India (about 127,500 cervical cancers a year) and for the global elimination target. It also removed the main barrier to India's national programme with its home-made vaccine.
- Non-randomised comparison of dose groups; confounding by who happened to receive fewer doses cannot be fully excluded.
- Endpoint is persistent infection, not cervical cancer, although the link is well established.
- Quadrivalent vaccine; nonavalent and bivalent products rely on separate evidence (KEN SHE, Costa Rica).
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