Background: In resource-poor settings, cold
chain requirements present barriers for vaccine delivery. We
evaluated the immunogenicity and safety of tetanus toxoid (TT)
vaccine in “Controlled Temperature Chain” (CTC; up to 40 °C for
<30 days before administration), compared to standard cold chain
(SCC; 2–8 °C). Prior to the study, stability parameters of TT–CTC
were shown to meet international requirements. Methods: A cluster
randomized, non-inferiority trial was conducted in Moïssala
district, Chad, December 2012–March 2013. Thirty-four included
clusters were randomized to CTC or SCC. Women aged 14–49 years,
eligible for TT vaccination and with a history of ≤1 TT dose,
received two TT doses 4 weeks apart. Participants were blinded to
allocation strategy. Tetanus antibody titers were measured using
standard ELISA at inclusion and 4 weeks post-TT2. Primary outcome
measures were post-vaccination seroconversion and fold-increase in
geometric mean concentrations (GMC). Non-inferiority was by
seroconversion difference (TTSCC − TTCTC) <5% and ratio of GMCs
(TTSCC/TTCTC) <1.5. Adverse events were monitored at health
centers and at next contact with participants. Results: A total of
2128 women (CTC = 1068; SCC = 1060) were recruited. Primary
intention to vaccinate analysis included 1830 participants; 272 of
these were included in the seroconversion analysis. Seroconversion
was reached by >95% of participants; upper 95%CI of the
difference was 5.6%. Increases in GMC were over 4-fold; upper 95%CI
of GMC ratio was 1.36 in the adjusted analysis. Few adverse events
were recorded. Conclusions: This study demonstrates the
immunogenicity and safety of TT in CTC at <40 °C for <30
days. The high proportion of participants protected at baseline
results in a reduction of power to detect a 5% non-inferiority
margin. However, results at a 10% non-inferiority margin, the
comparable GMC increases and vaccine\'s stability demonstrated in
the preliminary phase indicate that CTC can be an alternative
strategy for TT delivery in situations where cold chain cannot be
maintained.
Année de publication
2014
Catégories
- Vaccins et dispositifs d'administration
Mots-clés
- Chaîne de température contrôlée (CTC)
Références sur le sujet
CTC_JOURNAL
Titre | Auteur | Année | Type | Langue |
A cluster randomized non-inferiority field trial on the immunogenicity and safety of tetanus toxoid vaccine kept in controlled temperature chain compared to cold chain | Rebecca F. Grais, Primitive Gakima, Paul Baoundoh, Mbaihol Tamadji, Martha H. Roper, Florence Fermon, Céline Langendorf, Camille Domicent, Aitana Juan-Giner, Simona Zipursky | 2014 | Journal article | Anglais |
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 Gessner | 2014 | Journal article | Anglais |
An economic evaluation of the controlled temperature chain approach for vaccine logistics: evidence from a study conducted during a meningitis A vaccine campaign in Togo | Mvundura et all | 2017 | Journal article | Anglais |
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' approach | Shereen H. Mohamed, Osama A. Hady, Mona T. Kashef, Hamdallah Zedan | 2022 | Journal article | Anglais |
Benefits of using vaccines out of the cold chain: Delivering Meningitis A vaccine in a controlled temperature chain during the mass immunization campaign in Benin | Simona Zipursky, Mamoudou Harouna Djingarey, Jean-Claude Lodjo, Laifoya Olodo, Sylvestre Tiendrebeogo, Olivier Ronveaux | 2014 | Journal article | Anglais |
Can thermostable vaccines help address cold-chain challenges? Results from stakeholder interviews in six low- and middle-income countries | Debra D. Kristensen, Kate Bartholomew, Shirley Villadiego, Tina Lorenson | | Journal article | Anglais |
Cost-effectiveness of the controlled temperature chain for the hepatitis B virus birth dose vaccine in various global settings: a modelling study | Nick Scott, Anna Palmer, Christopher Morgan, Olufunmilayo Lesi, Wendy Spearman, Mark Sonderup, Margaret Hellard | 2018 | Journal article | Anglais |
Countries’ interest in a hepatitis B vaccine licensed for the controlled temperature chain; survey results from African and Western Pacific regions | Dörte Petit, Carole Tevi-Benissan, Joseph Woodring, Karen Hennessey, Anna-Lea Kahn | 2017 | Journal article | Anglais |
Economic benefits of keeping vaccines at ambient temperature during mass vaccination: the case of Meningitis A vaccine in Chad | Patrick Lydon et al. | 2014 | Journal article | Anglais |
Evidence of Extended Thermo-Stability of Typhoid Polysaccharide Conjugate Vaccines | Fang Gao, Alastair Logan, Sarah Davis, Barbara Bolgiano, Sjoerd Rijpkema, Gopal Singh, Sai D. Prasad, Samuel Pradeep Dondapati, Gurbaksh Singh Sounkhla | 2021 | Journal article | Anglais |
Extending supply chains and improving immunization coverage and equity through controlled temperature chain use of vaccines | Raja Rao, Debra Kristensen, Anna-Lea Kahn | 2017 | Journal article | Anglais |
Impact of Controlled Temperature Chain (CTC) approach on immunization coverage achieved during the preventive vaccination campaign against meningitis A using MenAfriVac in Togo in 2014 | Dadja 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 Ronveaux | 2017 | Journal article | Anglais |
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 study | Christopher P. Seaman, Christopher Morgan, Jess Howell, Yinzong Xiao, Wendy Spearman, Mark Sonderup | 2020 | Journal article | Anglais |