Evidence map›Paper›PMID 38297337›Full record

ArticleTropical diseases, travel medicine and vaccines2024

A phase II clinical trial of a Vi-DT typhoid conjugate vaccine in healthy Indonesian adolescents and adults: one-month evaluation of safety and immunogenicity.

Sukamto Koesnoe, Bernie Endyarni Medise, Iris Rengganis, Sri Rezeki Hadinegoro, Mita Puspita, Rini Mulia Sari, Jae Seung Yang, Sushant Sahastrabuddhe, Soedjatmiko, Hartono Gunardi and 6 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Tropical diseases, travel medicine and vaccines, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03460405 (Safety and Immunogenicity of Vi-DT Typhoid Conjugate Vaccine), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
1.4field-weighted citation impact, top 21% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03460405 phase2completednot on this map

Safety and Immunogenicity of Vi-DT Typhoid Conjugate Vaccine (Bio Farma) in Indonesian Adults, Adolescents, Children and Infants (Phase II)

TypeinterventionalSponsorPT Bio FarmaRan2018 to 2020Enrolled600ConditionsSafety Issues, ImmunogenicityArmsVi-DT Vaccine, Vi Polysaccharide Vaccine, IPV Vaccine
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 4 citations in OpenAlex.

  1. Typhoid conjugate vaccines for preventing typhoid fever (enteric fever).The Cochrane database of systematic reviews · 2025
    Pooled it
  2. Trial
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 3 institutions in 2 countries.

Sukamto KoesnoeDepartment of Internal Medicine, Faculty of Medicine Universitas Indonesia, Dr. Cipto Mangunkusumo General National Hospital, Jakarta, Indonesia.
Bernie Endyarni MediseDepartment of Child Health, Faculty of Medicine Universitas Indonesia, Dr. Cipto Mangunkusumo General National Hospital, Jalan Diponegoro no 71, Jakarta, 10340, Indonesia. bernie.medise@yahoo.com.
Iris RengganisDepartment of Internal Medicine, Faculty of Medicine Universitas Indonesia, Dr. Cipto Mangunkusumo General National Hospital, Jakarta, Indonesia.
Sri Rezeki HadinegoroDepartment of Child Health, Faculty of Medicine Universitas Indonesia, Dr. Cipto Mangunkusumo General National Hospital, Jalan Diponegoro no 71, Jakarta, 10340, Indonesia.
Mita PuspitaPT. Bio Farma, Bandung, Indonesia.
Rini Mulia SariPT. Bio Farma, Bandung, Indonesia.
Jae Seung YangInternational Vaccine Institute, Seoul, Republic of Korea.
Sushant SahastrabuddheInternational Vaccine Institute, Seoul, Republic of Korea.
SoedjatmikoDepartment of Child Health, Faculty of Medicine Universitas Indonesia, Dr. Cipto Mangunkusumo General National Hospital, Jalan Diponegoro no 71, Jakarta, 10340, Indonesia.
Hartono GunardiDepartment of Child Health, Faculty of Medicine Universitas Indonesia, Dr. Cipto Mangunkusumo General National Hospital, Jalan Diponegoro no 71, Jakarta, 10340, Indonesia.
Rini SekartiniDepartment of Child Health, Faculty of Medicine Universitas Indonesia, Dr. Cipto Mangunkusumo General National Hospital, Jalan Diponegoro no 71, Jakarta, 10340, Indonesia.
Angga WirahmadiDepartment of Child Health, Faculty of Medicine Universitas Indonesia, Dr. Cipto Mangunkusumo General National Hospital, Jalan Diponegoro no 71, Jakarta, 10340, Indonesia.
Aria KekalihCommunity Medicine Department, Faculty of Medicine Universitas Indonesia, Dr. Cipto Mangunkusumo General National Hospital, Jakarta, Indonesia.
Sreshta MukhiDepartment of Child Health, Faculty of Medicine Universitas Indonesia, Dr. Cipto Mangunkusumo General National Hospital, Jalan Diponegoro no 71, Jakarta, 10340, Indonesia.
Hindra Irawan SatariDepartment of Child Health, Faculty of Medicine Universitas Indonesia, Dr. Cipto Mangunkusumo General National Hospital, Jalan Diponegoro no 71, Jakarta, 10340, Indonesia.
Novilia Sjafri BachtiarPT. Bio Farma, Bandung, Indonesia.
University of Indonesia · IDPT Bio Farma (Indonesia) · IDInternational Vaccine Institute · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTyphoid fever is commonly found until today, especially in developing countries. It has fatal complications and measures must be taken to reduce the incidence of typhoid. Vaccinations are a key factor in prevention. This is a phase II randomized observer-blind clinical trial on a novel Vi-DT conjugate vaccine on 200 subjects 12 to 40 years of age.

methodsSubjects were screened for eligibility after which a blood sample was taken and one dose of vaccine was administered. Investigational vaccine used was Vi-DT and control was Vi-PS. Twenty-eight days after vaccination, subjects visited for providing blood sample to assess immunogenicity and were asked about local and systemic adverse reactions that occurred in the first 28 days.

resultsSubjects had minor adverse reactions. Pain was the most common local reaction. Muscle pain was the most common systemic reaction. There were no serious adverse events up to 28 days post vaccination. Seroconversion rates were 100% in the Vi-DT group and 95.96% in the Vi-PS group. Post vaccination GMTs were increased in both groups but it was significantly higher in the Vi-DT group (p < 0.001).

conclusionsVi-DT typhoid conjugate vaccine is safe and immunogenic in healthy Indonesian subjects 12 to 40 years.

trial registrationApproved by ClinicalTrials.gov. CLINICAL TRIAL REGISTRATION NUMBER: NCT03460405. Registered on 09/03/2018. URL: https://clinicaltrials.gov/ct2/show/NCT03460405 .

Indexed as

Typhoid conjugate vaccineTyphoid FeverVi-DTVi-PS

Identifiers

PMID38297337
PMCPMC10832164
OpenAlexW4392787604

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.