Journal Article > ResearchFull Text
PLoS Negl Trop Dis. 2024 January 22; Volume 18 (Issue 1); e0011661.; DOI:10.1371/journal.pntd.0011661
Nesbitt RC, Asilaza VK, Gignoux EM, Koyuncu A, Gitahi P, et al.
PLoS Negl Trop Dis. 2024 January 22; Volume 18 (Issue 1); e0011661.; DOI:10.1371/journal.pntd.0011661
INTRODUCTION
Hepatitis E (HEV) genotypes 1 and 2 are the common cause of jaundice and acute viral hepatitis that can cause large-scale outbreaks. HEV infection is associated with adverse fetal outcomes and case fatality risks up to 31% among pregnant women. An efficacious three-dose recombinant vaccine (Hecolin) has been licensed in China since 2011 but until 2022, had not been used for outbreak response despite a 2015 WHO recommendation. The first ever mass vaccination campaign against hepatitis E in response to an outbreak was implemented in 2022 in Bentiu internally displaced persons camp in South Sudan targeting 27,000 residents 16–40 years old, including pregnant women.
METHODS
We conducted a vaccination coverage survey using simple random sampling from a sampling frame of all camp shelters following the third round of vaccination. For survey participants vaccinated in the third round in October, we asked about the onset of symptoms experienced within 72 hours of vaccination. During each of the three vaccination rounds, passive surveillance of adverse events following immunisation (AEFI) was put in place at vaccination sites and health facilities in Bentiu IDP camp.
RESULTS
We surveyed 1,599 individuals and found that self-reported coverage with one or more dose was 86% (95% CI 84–88%), 73% (95% CI 70–75%) with two or more doses and 58% (95% CI 55–61%) with three doses. Vaccination coverage did not differ significantly by sex or age group. We found no significant difference in coverage of at least one dose between pregnant and non-pregnant women, although coverage of at least two and three doses was 8 and 14 percentage points lower in pregnant women. The most common reasons for non-vaccination were temporary absence or unavailability, reported by 60% of unvaccinated people. Passive AEFI surveillance captured few mild AEFI, and through the survey we found that 91 (7.6%) of the 1,195 individuals reporting to have been vaccinated in October 2022 reported new symptoms starting within 72 hours after vaccination, most commonly fever, headache or fatigue.
CONCLUSIONS
We found a high coverage of at least one dose of the Hecolin vaccine following three rounds of vaccination, and no severe AEFI. The vaccine was well accepted and well tolerated in the Bentiu IDP camp community and should be considered for use in future outbreak response.
Hepatitis E (HEV) genotypes 1 and 2 are the common cause of jaundice and acute viral hepatitis that can cause large-scale outbreaks. HEV infection is associated with adverse fetal outcomes and case fatality risks up to 31% among pregnant women. An efficacious three-dose recombinant vaccine (Hecolin) has been licensed in China since 2011 but until 2022, had not been used for outbreak response despite a 2015 WHO recommendation. The first ever mass vaccination campaign against hepatitis E in response to an outbreak was implemented in 2022 in Bentiu internally displaced persons camp in South Sudan targeting 27,000 residents 16–40 years old, including pregnant women.
METHODS
We conducted a vaccination coverage survey using simple random sampling from a sampling frame of all camp shelters following the third round of vaccination. For survey participants vaccinated in the third round in October, we asked about the onset of symptoms experienced within 72 hours of vaccination. During each of the three vaccination rounds, passive surveillance of adverse events following immunisation (AEFI) was put in place at vaccination sites and health facilities in Bentiu IDP camp.
RESULTS
We surveyed 1,599 individuals and found that self-reported coverage with one or more dose was 86% (95% CI 84–88%), 73% (95% CI 70–75%) with two or more doses and 58% (95% CI 55–61%) with three doses. Vaccination coverage did not differ significantly by sex or age group. We found no significant difference in coverage of at least one dose between pregnant and non-pregnant women, although coverage of at least two and three doses was 8 and 14 percentage points lower in pregnant women. The most common reasons for non-vaccination were temporary absence or unavailability, reported by 60% of unvaccinated people. Passive AEFI surveillance captured few mild AEFI, and through the survey we found that 91 (7.6%) of the 1,195 individuals reporting to have been vaccinated in October 2022 reported new symptoms starting within 72 hours after vaccination, most commonly fever, headache or fatigue.
CONCLUSIONS
We found a high coverage of at least one dose of the Hecolin vaccine following three rounds of vaccination, and no severe AEFI. The vaccine was well accepted and well tolerated in the Bentiu IDP camp community and should be considered for use in future outbreak response.
Conference Material > Abstract
Nesbitt RC, Rumunu J, Asilaza VK, Gitahi P, Nkemenang P, et al.
MSF Scientific Day International 2023. 2023 June 7; DOI:10.57740/qdmj-8n51
INTRODUCTION
A three-dose recombinant vaccine against hepatitis E, Hecolin, has been licensed for use in China since 2011. While not recommended for routine use due to lack of evidence on burden in the general population, in 2015 WHO recommended the vaccine be considered in outbreaks. As of early 2022 however, the vaccine had not been used in outbreak settings. A reduced-dose vaccination schedule, if effective, could make the vaccine an important outbreak response tool. In response to an increase in hepatitis E cases in a camp for internally displaced people in Bentiu, South Sudan in late 2021, MSF and South Sudan’s MoH implemented the first ever mass reactive vaccination campaign against hepatitis E virus (HEV). Three vaccination rounds took place in March, April, and October 2022, targeting 26,848 individuals aged 16-40 years, including pregnant women. We set up enhanced surveillance and conducted a case-control study to estimate two-dose vaccine effectiveness (VE).
METHODS
All suspected cases presenting to the MSF hospital who were eligible for vaccination and provided consent were enrolled in the study, comprising a questionnaire, laboratory examinations and a follow-up visit after 2-4 weeks. Vaccine-eligible suspect cases were matched to community controls. We estimated twodose VE against probable (anti-HEV IgM positive with elevated alanine transaminase, or a four-fold rise in IgG in paired samples) and confirmed (HEV RNA positive) hepatitis E using conditional logistic regression models.
ETHICS
This study was approved by the MSF and South Sudan Ethics Review Boards.
RESULTS
Considering the period two weeks after the second vaccination round between 11 May and 30 December 2022, 287 vaccine-eligible suspect hepatitis E cases were enrolled, including one probable and 16 confirmed cases. Among probable and confirmed cases, two (11.8%) were vaccinated with two or more doses compared to 40 (40%) of their 100 matched controls. We estimated a VE of 86.5% (95% confidence interval, CI, 36.3–97.1) for one/two doses and 83.9% (95% CI, -33.1–98.1%) for two doses. In addition to this direct protection, we observed a 5.5-fold decrease in the incidence rate of probable/confirmed cases hepatitis E cases before and after the second dose campaign (including those not eligible for vaccination). Laboratory confirmation of hepatitis E infection is ongoing, and we expect to revise VE estimates and incidence based on these results.
CONCLUSION
Following the first mass reactive vaccination campaign against hepatitis E, incidence has declined. Preliminary VE estimates suggest that the short-term protection provided by this reduced dose regimen may be high and potentially sufficient for outbreak response.
CONFLICTS OF INTEREST
None declared
A three-dose recombinant vaccine against hepatitis E, Hecolin, has been licensed for use in China since 2011. While not recommended for routine use due to lack of evidence on burden in the general population, in 2015 WHO recommended the vaccine be considered in outbreaks. As of early 2022 however, the vaccine had not been used in outbreak settings. A reduced-dose vaccination schedule, if effective, could make the vaccine an important outbreak response tool. In response to an increase in hepatitis E cases in a camp for internally displaced people in Bentiu, South Sudan in late 2021, MSF and South Sudan’s MoH implemented the first ever mass reactive vaccination campaign against hepatitis E virus (HEV). Three vaccination rounds took place in March, April, and October 2022, targeting 26,848 individuals aged 16-40 years, including pregnant women. We set up enhanced surveillance and conducted a case-control study to estimate two-dose vaccine effectiveness (VE).
METHODS
All suspected cases presenting to the MSF hospital who were eligible for vaccination and provided consent were enrolled in the study, comprising a questionnaire, laboratory examinations and a follow-up visit after 2-4 weeks. Vaccine-eligible suspect cases were matched to community controls. We estimated twodose VE against probable (anti-HEV IgM positive with elevated alanine transaminase, or a four-fold rise in IgG in paired samples) and confirmed (HEV RNA positive) hepatitis E using conditional logistic regression models.
ETHICS
This study was approved by the MSF and South Sudan Ethics Review Boards.
RESULTS
Considering the period two weeks after the second vaccination round between 11 May and 30 December 2022, 287 vaccine-eligible suspect hepatitis E cases were enrolled, including one probable and 16 confirmed cases. Among probable and confirmed cases, two (11.8%) were vaccinated with two or more doses compared to 40 (40%) of their 100 matched controls. We estimated a VE of 86.5% (95% confidence interval, CI, 36.3–97.1) for one/two doses and 83.9% (95% CI, -33.1–98.1%) for two doses. In addition to this direct protection, we observed a 5.5-fold decrease in the incidence rate of probable/confirmed cases hepatitis E cases before and after the second dose campaign (including those not eligible for vaccination). Laboratory confirmation of hepatitis E infection is ongoing, and we expect to revise VE estimates and incidence based on these results.
CONCLUSION
Following the first mass reactive vaccination campaign against hepatitis E, incidence has declined. Preliminary VE estimates suggest that the short-term protection provided by this reduced dose regimen may be high and potentially sufficient for outbreak response.
CONFLICTS OF INTEREST
None declared
Conference Material > Poster
Nesbitt RC, Rumunu J, Asilaza VK, Gitahi P, Nkemenang P, et al.
MSF Scientific Day International 2023. 2023 June 7
Conference Material > Slide Presentation
Nesbitt RC, Rumunu J, Asilaza VK, Gitahi P, Nkemenang P, et al.
MSF Scientific Day International 2023. 2023 June 7; DOI:10.57740/0zh3-kk31