Trial of Pneumococcal Vaccine Schedules in Ho Chi Minh City, Vietnam

Summary

Pneumococcus is a group of bacteria that can cause pneumonia, meningitis and other diseases. These bacteria normally live in the nose of humans and are spread from person to person by touching or sneezing. There are vaccines available to protect against infection with these bacteria, and pneumococcus is currently the leading vaccine-preventable cause of death in young children. In countries where pneumococcal vaccine (PCV) has been introduced, there has been a big impact on the amount of disease caused by these bacteria. However, many countries, especially developing countries, are yet to introduce PCV as part of their routine immunizations. Currently a total of four doses of PCV is recommended, and the main barrier to vaccine introduction is cost. This study aims to identify a vaccination schedule to make PCV more effective and affordable for Vietnam and other developing countries. This study has two distinct purposes: 1) to compare different dosage schedules of PCV and 2) to compare different PCV vaccines. 1. Schedules of Synflorix (PCV10) involving a three, two or one dose PCV primary series and two booster options will be compared. Comparisons will be made firstly in terms of measures of immunity to the vaccine, and secondly in terms of the effect of vaccination on the carriage of bacteria in the nose. 2. The responses to PCV10 and Prevenar-13 (PCV13) will be compared, in the schedule most likely to be considered for global use. Again, comparisons will be made in terms of measures of immunity and effect on carriage in the nose. Infants aged two months will be randomly assigned to one of six study groups and will provide up to four blood samples for analysis of the measures of immunity and five nose swabs for analysis of carriage of bacteria. Infants will be followed up 8-9 times until the age of 24 months. An additional control group will be recruited at 18 months of age and also followed up until 24 months of age. The results of this study will be used to facilitate decision making, at global and national levels, regarding introduction of PCV.

Timeline

Start

2013-09-30

Primary completion

2016-01-27

Completion

2021-11-08

Publications

• Toh ZQ, Ma YY, Temple B, Anderson J, Far HH, Phan TV, Dai VTT, Huu TN, Toan NT, Bright K, Nation ML, Ortika BD, Nguyen C, Smith-Vaughan H, Satzke C, Mulholland K, Licciardi PV. Relationship between IL-17_A and pneumococcal carriage in children aged under two years: data from a randomised controlled trial in Vietnam. Cytokine. 2026 Feb;198:157094. doi: 10.1016/j.cyto.2025.157094. Epub 2025 Dec 23.
• Smith-Vaughan H, Temple B, Trang Dai VT, Hoan PT, Loc Thuy HN, Phan TV, Bright K, Toan NT, Uyen DY, Nguyen CD, Beissbarth J, Ortika BD, Nation ML, Dunne EM, Hinds J, Lai J, Satzke C, Huu TN, Mulholland K. Effect of different schedules of ten-valent pneumococcal conjugate vaccine on pneumococcal carriage in Vietnamese infants: results from a randomised controlled trial. Lancet Reg Health West Pac. 2022 Dec 3;32:100651. doi: 10.1016/j.lanwpc.2022.100651. eCollection 2023 Mar.
• Licciardi PV, Temple B, Dai VTT, Toan NT, Uyen D, Nguyen CD, Phan TV, Bright K, Marimla RA, Balloch A, Huu TN, Mulholland K. Immunogenicity of alternative ten-valent pneumococcal conjugate vaccine schedules in infants in Ho Chi Minh City, Vietnam: results from a single-blind, parallel-group, open-label, randomised, controlled trial. Lancet Infect Dis. 2021 Oct;21(10):1415-1428. doi: 10.1016/S1473-3099(20)30775-1. Epub 2021 Jun 23.
• Temple B, Nation ML, Dai VTT, Beissbarth J, Bright K, Dunne EM, Hinds J, Hoan PT, Lai J, Nguyen CD, Ortika BD, Phan TV, Thuy HNL, Toan NT, Uyen DY, Satzke C, Smith-Vaughan H, Huu TN, Mulholland K. Effect of a 2+1 schedule of ten-valent versus 13-valent pneumococcal conjugate vaccine on pneumococcal carriage: Results from a randomised controlled trial in Vietnam. Vaccine. 2021 Apr 15;39(16):2303-2310. doi: 10.1016/j.vaccine.2021.02.043. Epub 2021 Mar 19.
• Temple B, Toan NT, Dai VTT, Bright K, Licciardi PV, Marimla RA, Nguyen CD, Uyen DY, Balloch A, Huu TN, Mulholland EK. Immunogenicity and reactogenicity of ten-valent versus 13-valent pneumococcal conjugate vaccines among infants in Ho Chi Minh City, Vietnam: a randomised controlled trial. Lancet Infect Dis. 2019 May;19(5):497-509. doi: 10.1016/S1473-3099(18)30734-5. Epub 2019 Apr 8.
• Temple B, Toan NT, Uyen DY, Balloch A, Bright K, Cheung YB, Licciardi P, Nguyen CD, Phuong NTM, Satzke C, Smith-Vaughan H, Vu TQH, Huu TN, Mulholland EK. Evaluation of different infant vaccination schedules incorporating pneumococcal vaccination (The Vietnam Pneumococcal Project): protocol of a randomised controlled trial. BMJ Open. 2018 Jun 8;8(6):e019795. doi: 10.1136/bmjopen-2017-019795.

Drugs

Indications

No indication recorded.