Journal article

Evidence of Extended Thermo-Stability of Typhoid Polysaccharide Conjugate Vaccines

Typhoid conjugate vaccines (TCV) are effective in preventing enteric fever caused by Salmonella enterica serovar Typhi in Southeast Asia and Africa. To facilitate vaccination with the Vi capsular polysaccharide–tetanus toxoid conjugate vaccine, Typbar TCV, and allow it to be transported and stored outside a cold chain just prior to administration, an extended controlled-temperature conditions (ECTC) study was performed to confirm the quality of the vaccine at 40 °C for 3 days at the end of its shelf-life (36 months at 2–8 °C). Studies performed in parallel by the vaccine manufacturer, Bharat Biotech International Limited, and an independent national control laboratory (NIBSC) monitored its stability-indicating parameters: O-acetylation of the Vi polysaccharide, integrity of the polysaccharide–protein conjugate, and its molecular size and pH. ECTC samples stored at 40 °C and 45 °C in comparison with control samples stored at 4 °C and 55 or 56 °C, were shown to have stable O-acetylation and pH; only very slight increases in the percentage of free saccharide and corresponding decreases in molecular size were observed. The deoxycholate method for precipitating conjugated polysaccharide was very sensitive to small incremental increases in percentage of free saccharide, in line with storage temperature and duration. This extended ECTC study demonstrated minimal structural changes to the Vi polysaccharide and conjugate vaccine and a stable formulation following extended exposure to elevated temperatures for the desired durations. This outcome supports the manufacturer’s ECTC claim for the vaccine to be allowed to be taken outside the cold chain before its administration.

Languages

  • English

Publication year

2021

Type

Journal article

Categories

  • Supply chain & logistics

Diseases

  • Typhoid

Topic references

CTC_JOURNAL

TitleAuthorYearTypeLanguage
A cluster randomized non-inferiority field trial on the immunogenicity and safety of tetanus toxoid vaccine kept in controlled temperature chain compared to cold chainRebecca F. Grais, Primitive Gakima, Paul Baoundoh, Mbaihol Tamadji, Martha H. Roper, Florence Fermon, Céline Langendorf, Camille Domicent, Aitana Juan-Giner, Simona Zipursky2014Journal articleEnglish
A field based evaluation of adverse events following MenAfriVac® vaccine delivered in a controlled temperature chain (CTC) approach in Benin Christoph Steffen, Evariste Tokplonou, Philippe Jaillard, Roger Dia, Marie N Deye Bassabi Alladji, Bradford Gessner2014Journal articleEnglish
An economic evaluation of the controlled temperature chain approach for vaccine logistics: evidence from a study conducted during a meningitis A vaccine campaign in TogoMvundura et all2017Journal articleEnglish
Antivenoms, hepatitis B vaccine and oral polio vaccine can be considered for storage and handling outside the cold chain following the innovative 'controlled temperature chain' approachShereen H. Mohamed, Osama A. Hady, Mona T. Kashef, Hamdallah Zedan2022Journal articleEnglish
Benefits of using vaccines out of the cold chain: Delivering Meningitis A vaccine in a controlled temperature chain during the mass immunization campaign in BeninSimona Zipursky, Mamoudou Harouna Djingarey, Jean-Claude Lodjo, Laifoya Olodo, Sylvestre Tiendrebeogo, Olivier Ronveaux2014Journal articleEnglish
Can thermostable vaccines help address cold-chain challenges? Results from stakeholder interviews in six low- and middle-income countriesDebra D. Kristensen, Kate Bartholomew, Shirley Villadiego, Tina LorensonJournal articleEnglish
Cost-effectiveness of the controlled temperature chain for the hepatitis B virus birth dose vaccine in various global settings: a modelling studyNick Scott, Anna Palmer, Christopher Morgan, Olufunmilayo Lesi, Wendy Spearman, Mark Sonderup, Margaret Hellard2018Journal articleEnglish
Countries’ interest in a hepatitis B vaccine licensed for the controlled temperature chain; survey results from African and Western Pacific regionsDörte Petit, Carole Tevi-Benissan, Joseph Woodring, Karen Hennessey, Anna-Lea Kahn2017Journal articleEnglish
Economic benefits of keeping vaccines at ambient temperature during mass vaccination: the case of Meningitis A vaccine in ChadPatrick Lydon et al.2014Journal articleEnglish
Evidence of Extended Thermo-Stability of Typhoid Polysaccharide Conjugate VaccinesFang Gao, Alastair Logan, Sarah Davis, Barbara Bolgiano, Sjoerd Rijpkema, Gopal Singh, Sai D. Prasad, Samuel Pradeep Dondapati, Gurbaksh Singh Sounkhla2021Journal articleEnglish
Extending supply chains and improving immunization coverage and equity through controlled temperature chain use of vaccinesRaja Rao, Debra Kristensen, Anna-Lea Kahn2017Journal articleEnglish
Impact of Controlled Temperature Chain (CTC) approach on immunization coverage achieved during the preventive vaccination campaign against meningitis A using MenAfriVac in Togo in 2014Dadja Essoya Landoh, Anna-Lea Kahn, Anani Lacle, Kodjovi Adjeoda, Bayaki Saka, Issifou Yaya, Danladi Ibrahim Nassoury, Assima Kalao, Makawa-Sy Makawa, Nsiari-Mueyi Joseph Biey, Andre Bita, Yaovi Temfa Toke, Petit Dörte, Lucile Imboua, Olivier Ronveaux2017Journal articleEnglish
Use of controlled temperature chain and compact prefilled auto-disable devices to reach 2030 hepatitis B birth dose vaccination targets in LMICs: a modelling and cost-optimisation studyChristopher P. Seaman, Christopher Morgan, Jess Howell, Yinzong Xiao, Wendy Spearman, Mark Sonderup2020Journal articleEnglish

Added by: Moderator

Added on: 2023-11-30 17:40:55

Hits: 342