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KEN SHE (single-dose HPV vaccine)

One shot of HPV vaccine was 97.5% effective against the two most dangerous HPV types, making it realistic to vaccinate the whole world.

Vaccine efficacy 97.5% against persistent HPV16/18 infection at 18 months (NEJM Evidence 2022), sustained at 36 months. Together with the IARC India cohort and Costa Rica trial data, it underpinned the WHO 2022 recommendation for one- or two-dose schedules, adopted by more than 60 countries by 2025 and roughly doubling the number of girls a fixed vaccine supply can protect.

Setting
Kenyan women aged 15-20: single dose of bivalent or nonavalent HPV vaccine vs meningococcal control, endpoint persistent HPV16/18 infection
Phase
Phase 3
Sponsor
University of Washington / Bill & Melinda Gates Foundation
Registry
Headline result
Single-dose efficacy 97.5% against persistent HPV16/18.
Reported
2022
Enrolled
2275
Replication
IARC India cohort (Basu 2021) and Costa Rica ESCUDDO/CVT data show similar single-dose protection.

Outcomes

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In plain words
What these results mean for people, not percentages
2,275 people took part
Vaccine efficacy against persistent HPV16/18 infectionprimaryother endpoint
  • 97.5 out of 100 people reached this endpoint with Single dose nonavalent HPV.
  • There was no comparison group, so this number cannot tell you how much of the effect is due to the treatment.
  • This endpoint is not one of the standard survival or response measures; read it alongside the trial's primary result.
  • These results apply to the people the trial enrolled: Kenyan women aged 15-20: single dose of bivalent or nonavalent HPV vaccine vs meningococcal control, endpoint persistent HPV16/18 infection. People in a different situation may not see the same effect.

Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.

2,275 participants enrolled.

Vaccine efficacy against persistent HPV16/18 infectionprimary
Single dose nonavalent HPV97.5 of 100
Source
EndpointArmnValueHR (95% CI)pSource
Vaccine efficacy against persistent HPV16/18 infectionprimarySingle dose nonavalent HPV97.5%link
Replication
IARC India cohort (Basu 2021) and Costa Rica ESCUDDO/CVT data show similar single-dose protection.

Connected

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