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Fulltext Modeling the potential public health impact of different vaccination strategies with an omicron-adapted bivalent vaccine in Malaysia

Thakkar K, Spinardi J, Kyaw MH, Yang J, Mendoza CF, Dass M, et al.

Expert Rev Vaccines, 2023;22(1):714-725.
PMID: 37548520 DOI: 10.1080/14760584.2023.2245465

BACKGROUND: Coronavirus disease 2019 (COVID-19) case numbers have increased following the emergence of the Omicron variant. This study estimated the impact of introducing and increasing the coverage of an Omicron-adapted bivalent booster vaccine in Malaysia.
RESEARCH DESIGN AND METHODS: A combined cohort Markov decision tree model was used to compare booster vaccination with an Omicron-adapted bivalent COVID-19 vaccine versus no booster vaccination in Malaysia. The model utilized age-specific data from January 2021 to March 2022 derived from published sources. The outcomes of interest included case numbers, hospitalizations, deaths, medical costs, and productivity losses. The population was stratified into high-risk and standard-risk subpopulations, and the study evaluated the benefits of increased coverage in different age and risk groups.
RESULTS: Vaccinating only high-risk individuals and those aged ≥ 65 years was estimated to avert 274,313 cases, 33229 hospitalizations, 2,434 deaths, Malaysian ringgit (MYR) 576 million in direct medical costs, and MYR 579 million in indirect costs. Expanding vaccination coverage in the standard-risk population to 75% was estimated to avert more deaths (31%), hospitalizations (155%), infections (206%), direct costs (206%), and indirect costs (281%).
CONCLUSIONS: These findings support broader population Omicron-adapted bivalent booster vaccination in Malaysia with potential for significant health and economic gains.

Matched MeSH terms: Vaccines, Combined
Fulltext Haemato-immunological responses and effectiveness of feed-based bivalent vaccine against Streptococcus iniae and Aeromonas hydrophila infections in hybrid red tilapia (Oreochromis mossambicus × O. niloticus)

Monir MS, Yusoff SBM, Zulperi ZBM, Hassim HBA, Mohamad A, Ngoo MSBMH, et al.

BMC Vet Res, 2020 Jul 02;16(1):226.
PMID: 32615969 DOI: 10.1186/s12917-020-02443-y

BACKGROUND: Streptococcosis and Motile Aeromonad Septicemia (MAS) are important diseases of tilapia, Oreochromis spp. and causes huge economic losses in aquaculture globally. The feed-based vaccination may be an alternative to minimize major infectious diseases in tilapia. Thus, this study aims to evaluate the haemato-immunological responses and effectiveness of a newly developed feed-based killed bivalent vaccine against Streptococcus iniae and Aeromonas hydrophila in hybrid red tilapia. A total of 495 hybrid red tilapia of 61.23 ± 4.95 g were distributed into 5 groups (each with triplicate). The fish were immunized orally through bivalent (combined S. iniae and A. hydrophila) spray vaccine (BS group), bivalent formulate vaccine (BF group), monovalent S. iniae vaccine (MS group), monovalent A. hydrophila vaccine (MA group) and unvaccinated as a control group. The vaccine was orally administered on days 0, 14 and 42 applied feed-based bacterin at 5% body weight. The blood and spleen samples were collected from all groups on 7, 21 and 49 days post-vaccination, and also 96 h post-infection to assess their haemato-immune responses.
RESULTS: Compared with the unvaccinated group, leukocyte, lymphocytes, monocytes, granulocytes counts in vaccinated groups were significantly (P

Matched MeSH terms: Vaccines, Combined/administration & dosage; Vaccines, Combined/immunology; Vaccines, Combined/standards
Evaluation of efficacy evaluation of combination vaccine of Recombinant C-Terminal Fragments of ApxIA, ApxIIA and ApxIIIA in piglets

Moon JY, Kim WK, Choi YH, Choi MS, Hur J, Kang JY, et al.

Sains Malaysiana, 2017;46:217-221.

The efficacy of the combination vaccine of the individual C-terminal fragments of ApxIA, ApxIIA and ApxIIIA of Actinobacillus pleuropneumoniae (APP) was evaluated in piglets. Twenty piglets were divided equally into 2 groups (n=10). All piglets were intramuscularly primed at 4 week-of-age (0 week post prime inoculation (WPPI)) and were intramuscularly boosted at 6 week-of-age (2 WPPI). Group A piglets were inoculated with sterile PBS and group B piglets were inoculated with the combination vaccine. Concentrations of each of the C-terminal fragment-specific IgG as determined by ELISA were significantly higher in group B than in group A from 2 WPPI until the end of this study. Clinical signs were observed from only 10% of group B piglets after the challenge with the mixture of APP serotypes 1, 2 and 5 at 4 WPPI, while 50% of group A piglets were protected against APP infections. Overall, intramuscular inoculation with the vaccine candidate can efficiently protect piglets against APP infection.

Matched MeSH terms: Vaccines, Combined
Immuno-protective efficiency of feed-based whole-cell inactivated bivalent vaccine against Streptococcus and Aeromonas infections in red hybrid tilapia (Oreochromis niloticus × Oreochromis mossambicus)

Monir MS, Yusoff MSM, Zulperi ZM, Hassim HA, Zamri-Saad M, Amal MNA, et al.

Fish Shellfish Immunol, 2021 Jun;113:162-175.
PMID: 33857622 DOI: 10.1016/j.fsi.2021.04.006

Streptococcosis and motile aeromonad septicemia (MAS) are well-known diseases in tilapia culture, which cause mass mortality with significant economic losses. The development of feed-based bivalent vaccines in controlling these diseases has been initiated, however, the mechanisms of immunities and cross-protection in fish remain unclear. This study was conducted to assess the immuno-protective as well as the cross-protective efficacy of a newly developed feed-based bivalent vaccine against Streptococcus and Aeromonas infections in red hybrid tilapia. A total of five groups of fish were vaccinated orally through two different techniques; bivalent vaccine (inactivated Streptococcus iniae and Aeromonas hydrophila) sprayed on feed pellets (BS group); bivalent vaccine (inactivated S. iniae and A. hydrophila) incorporated in feed (BI group); monovalent inactivated S. iniae and A. hydrophila vaccine separately incorporated into feed as monovalent S. iniae (MS group) and monovalent A. hydrophila (MA group); and control group (without vaccine). The feed-based vaccine was delivered orally at 5% of body weight for five consecutive days. The booster doses were given in the same manner on weeks 2 and 6. Serum and skin mucus samples were collected to assess the IgM responses using indirect ELISA. The first administration of the feed-based vaccine stimulated the IgM levels that lasted until week 3, while the second booster ensured that the IgM levels remained high for a period of 16 weeks in the BI, MS and MA groups. The BI group developed a strong and significantly (P

Matched MeSH terms: Vaccines, Combined/immunology*
Influenza vaccine concurrently administered with a combination measles, mumps, and rubella vaccine to young children

Lum LC, Borja-Tabora CF, Breiman RF, Vesikari T, Sablan BP, Chay OM, et al.

Vaccine, 2010 Feb 10;28(6):1566-74.
PMID: 20003918 DOI: 10.1016/j.vaccine.2009.11.054

Children aged 11 to <24 months received 2 intranasal doses of live attenuated influenza vaccine (LAIV) or placebo, 35+/-7 days apart. Dose 1 was administered concomitantly with a combined measles, mumps, and rubella vaccine (Priorix). Seroresponses to measles and mumps were similar between groups. Compared with placebo, response rates to rubella in LAIV+Priorix recipients were statistically lower at a 15 IU/mL threshold (83.9% vs 78.0%) and the prespecified noninferiority criteria were not met. In a post hoc analysis using an alternate widely accepted threshold of 10 IU/mL, the noninferiority criteria were met (93.4% vs 89.8%). Concomitant administration with Priorix did not affect the overall influenza protection rate of LAIV (78.4% and 63.8% against antigenically similar influenza strains and any strain, respectively).

Matched MeSH terms: Vaccines, Combined/administration & dosage; Vaccines, Combined/immunology
Fulltext Immunogenicity and Safety of a Tetravalent Dengue Vaccine Administered Concomitantly or Sequentially With Quadrivalent Human Papillomavirus Vaccine in Boys and Girls 9-13 Years of Age in Malaysia: A Phase IIIb, Randomized, Open-label Study

Hassan J, Toh TH, Sivapunniam SK, Hasim R, Ghazali NF, Sulaiman S, et al.

Pediatr Infect Dis J, 2021 08 01;40(8):774-781.
PMID: 34250977 DOI: 10.1097/INF.0000000000003164

BACKGROUND: Incorporating dengue vaccination within existing vaccination programs could help improve dengue vaccine coverage. We assessed the immunogenicity and safety of a quadrivalent human papillomavirus (HPV) vaccine administered concomitantly or sequentially with a tetravalent dengue vaccine (CYD-TDV) in healthy children 9-13 years of age in Malaysia.
METHODS: In this phase IIIb, open-label, multicenter study (NCT02993757), participants were randomized 1:1 to receive 3 CYD-TDV doses 6 months apart and 2 doses of quadrivalent HPV vaccine concomitantly with, or 1 month before (sequentially), the first 2 CYD-TDV doses. Only baseline dengue-seropositive participants received the 3 doses. Antibody levels were measured at baseline and 28 days after each injection using an enzyme-linked immunosorbent assay for HPV-6, -9, -16 and -18, and the 50% plaque reduction neutralization test for the 4 dengue serotypes; immunogenicity results are presented for baseline dengue-seropositive participants. Safety was assessed throughout the study for all participants.
RESULTS: At baseline, 197 of 528 (37.3%) randomized participants were dengue-seropositive [n = 109 (concomitant group) and n = 88 (sequential group)]. After the last HPV vaccine dose, antibody titers for HPV among baseline dengue-seropositive participants were similar between treatment groups, with between-group titer ratios close to 1 for HPV-6 and 0.8 for HPV-11, -16, and -18. After CYD-TDV dose 3, dengue antibody titers were similar between treatment groups for all serotypes [between-group ratios ranged from 0.783 (serotype 2) to 1.07 (serotype 4)]. No safety concerns were identified.
CONCLUSIONS: The immunogenicity and safety profiles of CYD-TDV and quadrivalent HPV vaccines were unaffected when administered concomitantly or sequentially in dengue-seropositive children.

Matched MeSH terms: Vaccines, Combined/administration & dosage*; Vaccines, Combined/immunology
Fulltext Live vaccines against bacterial fish diseases: A review

Mohd-Aris A, Muhamad-Sofie MHN, Zamri-Saad M, Daud HM, Ina-Salwany MY

Vet World, 2019 Nov;12(11):1806-1815.
PMID: 32009760 DOI: 10.14202/vetworld.2019.1806-1815

Fish diseases are often caused either by bacteria, viruses, fungi, parasites, or a combination of these pathogens. Of these, bacterial fish diseases are considered to be a major problem in the aquaculture industry. Hence, the prevention of such diseases by proper vaccination is one of the integral strategies in fish health management, aimed at reducing the fish mortality rate in the aquaculture farms. Vaccination offers an effective yet low-cost solution to combat the risk of disease in fish farming. An appropriate vaccination regime to prevent bacterial diseases offers a solution against the harmful effects of antibiotic applications. This review discusses the role of live-attenuated vaccine in controlling bacterial diseases and the development of such vaccines and their vaccination strategy. The current achievements and potential applications of live-attenuated and combined vaccines are also highlighted. Vaccine development is concluded to be a demanding process, as it must satisfy the requirements of the aquaculture industry.

Matched MeSH terms: Vaccines, Combined
Fulltext Economic impact of switching from partially combined vaccine "Pentaxim® and hepatitis B" to fully combined vaccine "Hexaxim®" in the Malaysian National Immunization Program

Aljunid SM, Al Bashir L, Ismail AB, Aizuddin AN, Rashid SAZA, Nur AM

BMC Health Serv Res, 2022 Jan 05;22(1):34.
PMID: 34986870 DOI: 10.1186/s12913-021-07428-7

BACKGROUND: The decision to implement new vaccines should be supported by public health and economic evaluations. Therefore, this study was primarily designed to evaluate the economic impact of switching from partially combined vaccine (Pentaxim® plus hepatitis B) to fully combined vaccine (Hexaxim®) in the Malaysian National Immunization Program (NIP) and to investigate healthcare professionals (HCPs)' and parents'/caregivers' perceptions.
METHODS: In this economic evaluation study, 22 primary healthcare centers were randomly selected in Malaysia between December 2019 and July 2020. The baseline immunization schedule includes switching from Pentaxim® (four doses) and hepatitis B (three doses) to Hexaxim® (four doses), whereas the alternative scheme includes switching from Pentaxim® (four doses) and hepatitis B (three doses) to Hexaxim® (four doses) and hepatitis B (one dose) administered at birth. Direct medical costs were extracted using a costing questionnaire and an observational time and motion chart. Direct non-medical (cost for transportation) and indirect costs (loss of productivity) were derived from parents'/caregivers' questionnaire. Also, HCPs' and parent's/caregivers' perceptions were investigated using structured questionnaires.
RESULTS: The cost per dose of Pentaxim® plus hepatitis B vs. Hexaxim® for the baseline scheme was Malaysian ringgit (RM) 31.90 (7.7 United States dollar [USD]) vs. 17.10 (4.1 USD) for direct medical cost, RM 54.40 (13.1 USD) vs. RM 27.20 (6.6 USD) for direct non-medical cost, RM 221.33 (53.3 USD) vs. RM 110.66 (26.7 USD) for indirect cost, and RM 307.63 (74.2 USD) vs. RM 155.00 (37.4 USD) for societal (total) cost. A similar trend was observed for the alternative scheme. Compared with Pentaxim® plus hepatitis B, total cost savings per dose of Hexaxim® were RM 137.20 (33.1 USD) and RM 104.70 (25.2 USD) in the baseline and alternative scheme, respectively. Eighty-four percent of physicians and 95% of nurses supported the use of Hexaxim® in the NIP. The majority of parents/caregivers had a positive perception regarding Hexaxim® vaccine in various aspects.
CONCLUSIONS: Incorporation of Hexaxim® within Malaysian NIP is highly recommended because the use of Hexaxim® has demonstrated substantial direct and indirect cost savings for healthcare providers and parents/caregivers with a high percentage of positive perceptions, compared with Pentaxim® plus hepatitis B.
TRIAL REGISTRATION: Not applicable.

Matched MeSH terms: Vaccines, Combined
Fulltext Parents' and healthcare professionals' perception toward the introduction of a new fully liquid hexavalent vaccine in the Malaysian national immunization program: a cross-sectional study instrument development and its application

Al Bashir L, Ismail A, Aljunid SM

Front Immunol, 2023;14:1052450.
PMID: 37180162 DOI: 10.3389/fimmu.2023.1052450

A newly developed fully liquid hexavalent vaccine that comprises six antigens for Diphtheria, Tetanus, acellular Pertussis, Inactivated Poliomyelitis, Haemophilus Influenza type b., and Hepatitis B, is proposed to be introduced in the Malaysian national immunization program, instead of the non-fully liquid pentavalent vaccine and monovalent Hepatitis B vaccine that is currently employed in the immunization schedule. Although the introduction of new vaccines is a necessary intervention, it still needs to be accepted by parents and healthcare professionals. Hence, this study aimed to develop three structured questionnaires and to investigate the participants' perception and acceptability toward the incorporation of the new fully liquid hexavalent vaccine. A cross-sectional study was conducted among a sample of 346 parents, 100 nurses, and 50 physicians attending twenty-two primary health care centers in the states of Selangor and the Federal Territory of Kuala Lumpur and Putrajaya during 2019-2020. The study found that Cronbach's alpha coefficients for the study instruments ranged from 0.825 to 0.918. Principal components analysis produced a good fit with KMO>0.6. For the parents' perception questionnaire, the only extracted factor explained 73.9 % of the total variance; for the nurses' perception toward a non-fully and fully liquid combined vaccine, there was a sole extracted factor that explained 65.2 % and 79.2% of the total variance, respectively. Whereas for the physicians' perception, there was one factor extracted that explains 71.8 % of the total variance. The median score for all the questionnaire items ranged from 4 to 5 (Q1 and Q3 vary between 3-5). Parents' ethnicity was significantly associated (P-value ≤ 0.05) with the perception that the new hexavalent vaccine would reduce their transportation expenses. Moreover, a significant association (P-value ≤ 0.05) was found between physicians' age and the perception of the hexavalent vaccine's ability to decrease patient overcrowding in primary healthcare centers. The instruments used in this study were valid and reliable. Parents of Malay ethnicity were the most concerned about transportation expenses since they have the lowest income and are more concentrated in rural areas compared to other races. Younger physicians were concerned about reducing patient crowding and hence reducing their workload and burnout.

Matched MeSH terms: Vaccines, Combined
Four is better than nine. a combined diphtheria-tetanus-pertussis-hepatitis B-Haemophilus influenzae type b vaccine for routine immunization in Malaysia

Wong SL, Soosai P, Teoh YL, Han HH, Lefevre I, Bock HL

Southeast Asian J Trop Med Public Health, 2008 May;39(3):474-83.
PMID: 18564687

Malaysian infants would have to receive nine injections during the first few months of life in order to be protected against disease caused by hepatitis B (HBV), diphtheria, tetanus, pertussis and Haemophilus influenzae type b (Hib) if single HBV and Hib vaccines were used. We evaluated a combined DTPw-HBV/Hib vaccine administered at 1.5, 3 and 5 months after a birth dose of hepatitis B vaccine (HBV). One month after completion of the primary vaccination, 99% of subjects had seroprotective anti-HBV antibody levels, and at least 98% had seroprotective antibodies against diphtheria, tetanus, and Hib, and were seropositive for pertussis antibodies. The immune response to the combined vaccine was comparable to that induced by separate injections with DTPw, HBV and Hib vaccines. Overall, the DTPw-HBV/Hib vaccine was as well tolerated as separate administration of DTPw, HBV and Hib vaccines. The combined DTPw-HBV/Hib vaccine induces protection against five diseases as recommended in the Malaysian routine vaccination schedule. Use of the combined DTPw-HBV/Hib vaccine can reduce the required number of injections from nine to four in the first few months of life.

Matched MeSH terms: Vaccines, Combined/administration & dosage; Vaccines, Combined/adverse effects; Vaccines, Combined/immunology
Fulltext Immunogenicity and protection efficacy of enhanced fitness recombinant Salmonella Typhi monovalent and bivalent vaccine strains against acute toxoplasmosis

Loh FK, Nathan S, Chow SC, Fang CM

Pathog Glob Health, 2021 09;115(6):392-404.
PMID: 33525974 DOI: 10.1080/20477724.2021.1881369

The proficiency of Salmonella Typhi to induce cell-mediated immunity has allowed its exploitation as a live vector against the obligate intracellular protozoan Toxoplasma gondii. T. gondii vaccine research is of great medical value due to the lack of a suitable toxoplasmosis vaccine. In the present work, we integrated T. gondii antigen into a growth-dependent chromosome locus guaBA of S. Typhi CVD910 strain to form recombinant S. Typhi monovalent CVD910-SAG1 expressed T. gondii SAG1 antigen and monovalent CVD910-GRA2 expressed T. gondii GRA2 antigen. Furthermore, a low-copy stabilized recombinant plasmid encoding SAG1 antigen was transformed into CVD910-GRA2 to form bivalent CVD910-GS strain. An osmolarity-regulated promoter was also incorporated to control the gene transcription, whereas clyA export protein was included to translocate the antigen out of the cytoplasm. Both CVD910-GRA2 and CVD910-GS displayed healthy growth fitness and readily expressed the encoded T. gondii antigens. When administered in vivo, CVD910-GS successfully induced both humoral and cellular immunity in the immunized BALB/c mice, and extended mice survival against virulent T. gondii. In particular, the mice immunized with bivalent CVD910-GS presented the highest titers of IgG, percentages of CD4+ T, CD8+ T, B cells and memory T cells, and total IgG+ memory B cells as compared to the CVD910-GRA2 and control strains. The CVD910-GS group also generated mixed Th1/Th2 cytokine profile with secretions of IFN-ɣ, IL-2 and IL-10. This study demonstrated the importance of enhancing live vector fitness to sustain heterologous antigen expression for eliciting robust immune responses and providing effective protection against pathogen.

Matched MeSH terms: Vaccines, Combined
Fulltext Vaccine Efficacy of a Newly Developed Feed-Based Whole-Cell Polyvalent Vaccine against Vibriosis, Streptococcosis and Motile Aeromonad Septicemia in Asian Seabass, Lates calcarifer

Mohamad A, Zamri-Saad M, Amal MNA, Al-Saari N, Monir MS, Chin YK, et al.

Vaccines (Basel), 2021 Apr 10;9(4).
PMID: 33920311 DOI: 10.3390/vaccines9040368

Multiple infections of several bacterial species are often observed under natural farm conditions. The infections would cause a much more significant loss compared to a single infectious agent. Vaccination is an essential strategy to prevent diseases in aquaculture, and oral vaccination has been proposed as a promising technique since it requires no handling of the fish and is easy to perform. This research attempts to develop and evaluate a potential feed-based polyvalent vaccine that can be used to treat multiple infections by Vibrios spp., Streptococcus agalactiae, and Aeromonas hydrophila, simultaneously. The oral polyvalent vaccine was prepared by mixing formalin-killed vaccine of V. harveyi, S. agalactiae, and A. hydrophila strains with commercial feed pellet, and palm oil as an adjuvant was added to improve their antigenicity. Thereafter, a vaccinated feed pellet was tested for feed quality analysis in terms of feed stability in water, proximate nutrient analysis, and palatability, safety, and growth performance using Asian seabass, Lates calcarifer as a fish host model. For immune response analysis, a total of 300 Asian seabass juveniles (15.8 ± 2.6 g) were divided into two groups in triplicate. Fish of group 1 were not vaccinated, while group 2 was vaccinated with the feed-based polyvalent vaccine. Vaccinations were carried out on days 0 and 14 with oral administration of the feed containing the bacterin at 5% body weight. Samples of serum for antibody and lysozyme study and the spleen and gut for gene expression analysis were collected at 7-day intervals for 6 weeks. Its efficacy in protecting fish was evaluated in aquarium challenge. Following vaccination by the polyvalent feed-based vaccine, IgM antibody levels showed a significant (p < 0.05) increase in serum against Vibrio harveyi, Aeromonas hydrophila, and Streptococcus agalactiae and reached the peak at week 3, 5, and 6, respectively. The high-stimulated antibody in the serum remained significantly higher than the control (p < 0.05) at the end of the 6 weeks vaccination trial. Not only that, but the serum lysozyme level was also increased significantly at week 4 (p < 0.05) as compared to the control treatment. The immune-related gene, dendritic cells, C3, Chemokine ligand 4 (CCL4), and major histocompatibility complex class I (MHC I) showed significantly higher expression (p < 0.05) after the fish were vaccinated with the oral vaccine. In the aquarium challenge, the vaccine provided a relative percentage survival of 75 ± 7.1%, 80 ± 0.0%, and 80 ± 0.0% after challenge with V. harveyi, A. hydrophila, and S. agalactiae, respectively. Combining our results demonstrate that the feed-based polyvalent vaccine could elicit significant innate and adaptive immunological responses, and this offers an opportunity for a comprehensive immunization against vibriosis, streptococcosis, and motile aeromonad septicemia in Asian seabass, Lates calcarifer. Nevertheless, this newly developed feed-based polyvalent vaccination can be a promising technique for effective and large-scale fish immunization in the aquaculture industry shortly.

Matched MeSH terms: Vaccines, Combined

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