Havrix

Manufactured by GlaxoSmithKline

Sourced in Belgium

Havrix is a laboratory equipment product manufactured by GlaxoSmithKline. It is designed to perform specific functions in a laboratory setting. The core function of Havrix is to facilitate the analysis and testing of samples, but a detailed description cannot be provided while maintaining an unbiased and factual approach.

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Lab products found in correlation

Typherix, by GlaxoSmithKline (3 mentions) Cervarix, by GlaxoSmithKline (3 mentions) Prevnar13, by Pfizer (1 mentions) Prevenar13, by Pfizer (1 mentions) Twinrix, by GlaxoSmithKline (1 mentions)

12 protocols using havrix

Pneumococcal and Hepatitis A Vaccine Administration

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Prevnar13® (Pfizer Inc., USA) contains polysaccharides of 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) conjugated to diphtheria toxoid (DT) variant CRM197, adjuvanted with aluminium phosphate.
Havrix® (GSK, Belgium) contains an inactivated HM175 hepatitis A virus (HAV) strain (1440 ELISA units/dose) adsorbed onto aluminium hydroxide. Epaxal® (Crucell/Janssen, the Netherlands) contains an inactivated RG-SB HAV strain (24 IU/dose) administered in an immunopotentiating reconstituted influenza virosome.
Prevnar13® (0.5 mL) and/or Havrix® (1.0 mL) or Epaxal® (0.5 mL) were administered intramuscularly in the deltoid region in both arms (PCV13þHepA group) or nondominant arm (PCV13 and HepA groups).

Riekkinen M., Pakkanen S.H., Hutse V., Roukaerts I., Ollgren J., Käyhty H., Herzog C., Rombo L, & Kantele A. (2023). Coadministered pneumococcal conjugate vaccine decreases immune response to hepatitis A vaccine: a randomized controlled trial. Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases, 29(12).

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Cluster-Randomized Vi Vaccine Trial

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The cluster-randomized trial of Vi capsular polysaccharide typhoid vaccine was initiated in 2004 (ClinicalTrials.gov reference number: NCT00125008). A total of 37,673 individuals, excluding pregnant and lactating women, aged ≥2 years were vaccinated with one dose of either: 1) Vi vaccine (Typherix, GlaxoSmithKline) containing 25μg of Vi polysaccharide; or 2) inactivated hepatitis A (HepA) vaccine (Havrix, GlaxoSmithKline). In the surveillance, participants from the study area who presented at one of five study clinics were examined by a study physician, and for each fever visit, defined as a patient who presented with a history of fever lasting at least 3 days, a blood culture was performed. We defined a typhoid visit as a fever visit in which S. Typhi was isolated from a blood culture, with the onset of the illness as the date of fever onset.

Im J., Islam M.T., Kim D.R., Ahmmed F., Chon Y., Zaman K., Khan A.I., Ali M., Sur D., Kanungo S., Dutta S., Bhattacharya S.K., Dougan G., Holt K.E., Marks F., Kim J.H., Qadri F, & Clemens J.D. (2020). Protection conferred by typhoid fever against recurrent typhoid fever in urban Kolkata. PLoS Neglected Tropical Diseases, 14(8), e0008530.

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Vi Vaccine and Hepatitis A Immunization

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Each dose of Vi vaccine (Typherix, GlaxoSmithKline) contained 25 μg of Vi polysaccharide. The control agent, inactivated HAV (Havrix, GlaxoSmithKline), contained 720 IU of inactivated hepatitis A virus for children 2–18 y of age and 1440 IU for adults. Each vaccine was administered by i.m. injection in a participant and observer blinded fashion. The vaccines were administered between 27 November and 31 December 2004. Residents ≥24 mo of age, without subjective or objective fever and not pregnant or lactating, were eligible to receive vaccine after giving written informed consent (guardian in case of minors). Vaccination was done in project vaccination centres set up in each cluster.

Ali M., Sur D., Kanungo S., Qadri F., Kim D.R., Islam T., Im J., Ahmmed F., Chon Y., Khan A.I., Zaman K., Marks F., Dutta S., Bhattacharya S.K, & Clemens J.D. (2019). Re-evaluating herd protection by Vi typhoid vaccine in a cluster randomized trial. International Health, 12(1), 36-42.

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Long-term Cervical Cancer Vaccine Efficacy

Cited 2 times

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Costa Rica Vaccine Trial (CVT) evaluated the efficacy of the bivalent HPV16/18 vaccine (Cervarix, GlaxoSmithKline Biologicals, Rixensart, Belgium). CVT enrolled 7466 women aged 18–25 years during 2004–2005. Participants were randomised to three doses of Cervarix or the control hepatitis A virus vaccine (Havrix, GlaxoSmithKline Biologicals, Rixensart, Belgium). Participants were followed-up annually for 4 years (more frequently, if clinically indicated). Cervical samples from sexually experienced women were collected for cytology and HPV-DNA testing at study visits.10 (link) At year 4 (2009–2010), the control group received HPV vaccination and was exited from the study.11 (link)
CVT transitioned into a long-term follow-up (LTFU). The HPV vaccine arm returned for additional study visits and a new unvaccinated control group (UCG) was recruited for comparison.11 (link) The UCG consisted of 2836 women from the same birth cohort and geographical region as the original controls. UCG was recruited concurrent with CVT participants year 4 visits. UCG women underwent intensive screening to identify/treat prevalent disease at enrolment. During the LTFU, the HPV and UCG groups returned for visits at years 7, 9 and 11, with additional visits if clinically indicated. Cervical samples from sexually experienced women were collected for cytology and HPV DNA testing at study visits.11 (link)

Sierra M.S., Tsang S.H., Porras C., Herrero R., Sampson J.N., Cortes B., Schussler J., Wagner S., Carvajal L., Quint W., Kreimer A.R., Hu S., Rodriguez A.C., Romero B, & Hildesheim A. (2022). Analysis of cervical HPV infections among unvaccinated young adult women to inform vaccine strategies in this age group: the Costa Rica HPV Vaccine Trial. Sexually Transmitted Infections, 99(3), 180-186.

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Phase III Trial of Cervical Cancer Vaccine

Cited 1 time

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CVT was a publicly funded, four-year, community-based, randomized phase III clinical trial (registered with Clinicaltrials.gov NCT00128661) [15] (link). From 2004 to 2005, 7466 women were consented and randomized to receive either the AS04-HPV-16/18 vaccine (Cervarix®, GlaxoSmithKline Biologicals, Rixensart, Belgium) or a control hepatitis A vaccine (Havrix®,GlaxoSmithKline Biologicals) in a 1:1 ratio at 0, 1, and 6 months. Participants were followed annually for 4 years, with more frequent follow-up when clinically indicated. Protocols were approved by the Institutional Review Boards (IRB) of the U.S. National Cancer Institute, the Costa Rican INCIENSA (for the CVT) and the National University Review Board (for the Long-term follow-up [LTFU] component), and all participants signed informed consent.

Kreimer A.R., Herrero R., Sampson J.N., Porras C., Lowy D.R., Schiller J.T., Schiffman M., Rodriguez A.C., Chanock S., Jimenez S., Schussler J., Gail M.H., Safaeian M., Kemp T.J., Cortes B., Pinto L.A., Hildesheim A, & Gonzalez P. (2018). Evidence for single-dose protection by the bivalent HPV vaccine—Review of the Costa Rica HPV vaccine trial and future research studies. Vaccine, 36(32Part A), 4774-4782.

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Randomized HPV Vaccine Trial in Costa Rica

Cited 1 time

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CVT was a publicly funded, four-year, community-based, randomized phase III clinical trial (registered with Clinicaltrials.gov NCT00128661) [15 (link)]. From 2004 to 2005, 7,466 women were consented and randomized to receive either the AS04-HPV-16/18 vaccine (Cervarix^®, GlaxoSmithKline Biologicals, Rixensart, Belgium) or a control hepatitis A vaccine (Havrix^®, GlaxoSmithKline Biologicals) in a 1:1 ratio at 0, 1, and 6 months. Participants were followed annually for 4 years, with more frequent follow-up when clinically indicated. Protocols were approved by the Institutional Review Boards (IRB) of the U.S. National Cancer Institute, the Costa Rican INCIENSA (for the CVT) and the National University Review Board (for the Long-term follow-up [LTFU] component), and all participants signed informed consent.

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Vaccination and Serum Collection in Mice

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Commercial hepatitis A vaccine (HAVRIX, GlaxoSmithKline) was obtained via the clinic at the University Hospitals of Geneva (HUG). Mice were anesthetized with isoflurane inhalation and 50 µl of the proprietary vaccine formula was injected into the thigh muscle. As an adjuvant control, 50 µl of Alhydrogel adjuvant 2% diluted 1:20 in PBS was given to provide the equivalent alum content.
A SARS-CoV-2 vaccine was formulated in house using recombinant spike receptor binding domain (RBD) protein (aa319–591, kindly provided by the protein production core facility of the Ecole Polytechnique Fédérale de Lausanne (EPFL)) adsorbed to Alhydrogel adjuvant 2% to generate an emulsion with a concentration of 200 µg/ml. Mice were anesthetized with isoflurane inhalation and 50 µl of the vaccine formulation was injected into the thigh muscle.
28 days following vaccination, mice were euthanised and blood was collected from the vena cava. Blood samples were allowed to clot for 30 min at room temperature, then centrifuged at 10,000 × g for 10 min. Serum supernatant was aliquoted and frozen at −80 °C prior to analysis.

Ince L.M., Barnoud C., Lutes L.K., Pick R., Wang C., Sinturel F., Chen C.S., de Juan A., Weber J., Holtkamp S.J., Hergenhan S.M., Geddes-McAlister J., Ebner S., Fontannaz P., Meyer B., Vono M., Jemelin S., Dibner C., Siegrist C.A., Meissner F., Graw F, & Scheiermann C. (2023). Influence of circadian clocks on adaptive immunity and vaccination responses. Nature Communications, 14, 476.

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Randomized Cluster Typhoid and Hepatitis A Vaccine Trial

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Eighty clusters were assigned randomly to two groups of 40 clusters and received either a single-dose ViPS typhoid vaccine (Typherix, GSK, Philadelphia, PA) or a single-dose inactivated hepatitis A (Hep A) vaccine (Havrix, GSK, Philadelphia, PA). The vaccines were administered to participants who were 24 months and older. For this randomization, clusters were stratified by ward, size of population 18 years or younger, and size of population older than 18 years. Vaccination occurred between November 27 and December 31, 2004. Of 61,280 age-eligible individuals, 37,673 were vaccinated: 18,869 in the ViPS vaccine arm and 18,804 in the Hep A arm. The trial was masked at four levels: participant, care provider, investigator, and outcomes assessors.

Im J., Khanam F., Ahmmed F., Kim D.R., Kang S., Tadesse B.T., Chowdhury F., Ahmed T., Aziz A.B., Hoque M., Islam M.T., Park J., Liu X., Sur D., Pak G., Jeon H.J., Zaman K., Khan A.I., Qadri F., Marks F., Kim J.H, & Clemens J.D. (2022). Prevention of Typhoid Fever by Existing Improvements in Household Water, Sanitation, and Hygiene, and the Use of the Vi Polysaccharide Typhoid Vaccine in Poor Urban Slums: Results from a Cluster-Randomized Trial. The American Journal of Tropical Medicine and Hygiene, 106(4), 1149-1155.

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Phase II Trial of CVnCoV SARS-CoV-2 Vaccine

Cited 1 time

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The CVnCoV vaccine candidate is an LNP-formulated RNActive® SARS-CoV-2 vaccine that contains 6 or 12 µg mRNA encoding for a pre-fusion conformation-stabilized version of the full-length S-protein from wild-type SARS-CoV-2. The mRNA is encapsulated in four lipid components: cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), PEG-ylated lipid and a cationic lipid [12] (link), and is stored at −60℃ until use. Each 0·3 mL dose was administered by intramuscular injection in the deltoid muscle of the non-dominant arm. Age-appropriate control vaccines were a licensed hepatitis A vaccine (Havrix™, GSK, Rixensart, Belgium, lot AHAVB965BK in Panama; and Avaxim™, Sanofi Pasteur, Lyon, France, lot R3E148V in Peru) which is recommended for use in the 18–60 years groups, and a licensed pneumococcal vaccine (Prevenar13, Pfizer, Ireland; lots AN1061 and T019826 in Panama, and lot DP8378 in Peru) which is recommended for the over-60 participants, administered according to the manufacturers’ instructions.

Sáez-Llorens X., Lanata C., Aranguren E., Celis C.R., Cornejo R., DeAntonio R., Ecker L., Garrido D., Gil A.I., Gonzales M., Hess-Holtz M., Leroux-Roels G., Junker H., Kays S.K., Koch S.D., Lazzaro S., Mann P., Quintini G., Srivastava B., Vahrenhorst D., von Eisenhart-Rothe P., Wolz O.O, & Oostvogels L. (2022). Safety and immunogenicity of mRNA-LNP COVID-19 vaccine CVnCoV in Latin American adults: A phase 2 randomized study. Vaccine: X, 11, 100189.

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Long-term Hepatitis A Vaccine Persistence

Cited 1 time

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To minimise external factors that could bias our findings, the descriptive analysis focussed only on GSK vaccines that are formulated using the same technology and for which long-term data are available.
A search of the GSK clinical studies (available from https://www.gsk-studyregister.com/en/) identified clinical studies of vaccines containing inactivated hepatitis A antigen, either as standalone HAV (Havrix; GSK, Belgium) or combination HAB (Twinrix; GSK, Belgium). Studies with at least 10 years of follow-up of antibody persistence data were included, as well as any longer-term follow-up of these studies using mathematical modelling [8 (link), 9 (link)]. In order to extrapolate outcomes in children using data in adults, studies with data on adult vaccine doses of HAB 720 EU or HAV 1440 EU were selected. The group of subjects in the children study given paediatric doses of HAB 360 EU [12 (link)] was excluded as this dose is not used in clinical practice. Children were defined as anyone aged under 18 years old, as the recommended inactivated vaccination dose and schedule is the same for this age group.
All procedures in the studies involving human participants were performed in accordance with the Good Clinical Practice Guidelines, as defined by the International Conference on Harmonization, the Declaration of Helsinki and its later amendments or comparable ethical standards.

Agrawal A., Kolhapure S., Andani A., Ota M.O., Badur S., Karkada N, & Mitra M. (2020). Long-Term Persistence of Antibody Response with Two Doses of Inactivated Hepatitis A Vaccine in Children. Infectious Diseases and Therapy, 9(4), 785-796.

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