Efficacy of Single-Dose Human Papillomavirus Vaccination among Young African Women
- Study type
- Clinical trial
- Design
- Randomised, multicentre, double-blind, controlled trial
- Sample size
- 2275 women
- Source
- NEJM Evidence · 2022
- Trial registration
- NCT03675256
In plain words
In this study of more than 2200 young Kenyan girls and women, just one dose of HPV vaccine protected very well against long-lasting infection with the high-risk types of this virus that cause cervical cancer. The protection was similar to the results reported with several doses. Follow-up lasted 18 months, and the rate of serious side effects did not differ much between the groups (about 4.5% to 5.2%).
Key results
Treatment arms and regimens
A single dose of 9-valent HPV vaccine (Gardasil 9; covering HPV 16/18/31/33/45/52/58/6/11) at baseline; meningococcal vaccine (MenVeo) delayed. 758 participants.
A single dose of bivalent HPV vaccine (Cervarix; covering HPV 16/18) at baseline; meningococcal vaccine (MenVeo) delayed. 760 participants.
Meningococcal vaccine (MenVeo) at baseline and 9-valent HPV vaccine delayed (after the end of the comparison period). 757 participants.
Source of the regimen details: Abstract and full text of the paper (PMC9172784) and ClinicalTrials.gov NCT03675256 (vaccine brand names and delayed vaccination)
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Study population
Kenyan women aged 15 to 20 years. The primary analysis population (mITT) included participants who were HPV antibody-negative at baseline and HPV DNA-negative at baseline and month 3.
Inclusion criteria (full text): sexually active with 1 to 5 lifetime sexual partners and resident in the study area. Exclusion criteria: positive HIV test, prior HPV vaccination, allergy to vaccine components or latex, pregnancy, hysterectomy or history of immunodeficiency.
Endpoints
Primary endpoint: new persistent infection with vaccine HPV genotypes up to month 18. Cervical swabs at baseline and every 6 months, and a vaginal swab at month 3, were tested for HPV DNA. Baseline serum was also tested for HPV antibodies.
Safety and side effects
The rate of serious adverse events ranged from 4.5% to 5.2% depending on the group.
Clinical significance and place in guidelines
These results show that single-dose HPV vaccination can be effective in preventing persistent HPV infection and could make vaccination programmes simpler and cheaper. However, the study endpoint was persistent infection up to 18 months, not cancer or precancerous lesions. The status of formal recommendations and current guidelines on the single-dose schedule should be checked separately.
Limitations
Follow-up was 18 months and the primary endpoint was persistent HPV infection, not precancerous lesions or cervical cancer. The study population was Kenyan women aged 15 to 20 years. Long-term durability of protection needs to be assessed in long-term follow-up.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.