Journal article

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

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.

Languages

  • English

Publication year

2014

Publisher

Elsevier

Journal

Vaccine

Volume

47

Type

Journal article

Categories

  • Vaccines & delivery devices

Diseases

  • Tetanus

Countries

  • Chad

Tags

  • CTC

WHO Regions

  • African Region

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