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diphtheria+tetanus+pertussis combined vaccine

✓ Approved

China National Pharmaceutical · Cell-based Therapies · Cell-based Therapies

What is diphtheria+tetanus+pertussis combined vaccine?

diphtheria+tetanus+pertussis combined vaccine is a cell-based therapies developed by China National Pharmaceutical. It is approved for therapeutic indications via injectable (others) or intramuscular (im) injection.

Drug Profile

CompanyChina National Pharmaceutical
Drug ClassCell-based Therapies, Vaccine
RouteInjectable (Others), Intramuscular (IM) Injection
StatusApproved
Sources: ClinicalTrials.gov, China National Pharmaceutical

Therapeutic Indications

diphtheria+tetanus+pertussis combined vaccine is developed for 3 unique indications across 1 therapeutic area.

Therapeutic AreaConditionPhase
Infections and infestationsDiphtheria✓ Approved
Infections and infestationsPertussis✓ Approved
Infections and infestationsTetanus✓ Approved

Related Research Articles

PubMedmedRxiv : the preprint server for health sciences2026-07-17

Pre-existing antibodies predict protection while mucosal inflammation correlates with symptomatic Bordetella pertussis infection.

Willemsen Lisa L, Ren Ziyuan Z, Shinde Pramod P, Thrupp Nicola N et al.

Despite decades of widespread vaccination, whooping cough caused by Bordetella pertussis (Bp) continues to circulate globally. To define correlates of protection and mechanisms underlying symptom development, we characterized systemic and mucosal immune responses in a controlled human infection model of Bp ( NCT05136599 ). Healthy vaccinated adults were intranasally challenged with escalating Bp doses and classified as symptomatic, asymptomatic, or non-infected. Longitudinal sampling of blood and nasal mucosa allowed mapping of antibody titers, immune cell subset frequencies, cytokine concentrations, gene expression, and T cell activation and polarization. Non-infected participants exhibited significantly higher pre-challenge serum antigen-specific IgG titers. Post-challenge, only symptomatic participants developed robust antigen-specific IgG responses. Notably, infection-induced IgG responses displayed slower kinetics and a lower overall magnitude compared to the rapid day 7 peak observed following tetanus, diphtheria, and acellular pertussis (Tdap) booster vaccination. Furthermore, symptomatic infection was driven by pronounced nasal inflammation characterized by increased HLA-DRLJ myeloid cells and upregulated mucosal NF-κB signaling on day 7. Systemic immune responses were comparatively modest post-challenge: plasma cytokine concentrations decreased independently of clinical outcome, peripheral blood mononuclear cell transcriptomes and antigen-specific T cell activation and polarization remained largely unchanged. These findings identify pre-existing serum antibodies as potential correlates of protection from Bp infection and suggest that symptom development is associated with localized mucosal inflammation dominated by a myeloid cell response. The predominance of nasal over systemic immune activation highlights the importance of mucosal immunity in controlling Bp and provides critical insights to guide the design of next-generation vaccines aimed at preventing both disease and transmission.

PMID 42465938
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PubMedbioRxiv : the preprint server for biology2026-07-17

Exposure to P. falciparum and common cold viruses shape vaccine responses in early life.

Bach Florian F, Sigal George G, Wohlstadter Jacob J, Brown Rayven R et al.

Vaccine immunogenicity is consistently lower in low-income countries than in high-income settings, yet the factors driving this disparity remain incompletely understood. Using multiplexed electrochemiluminescence serology, we measured IgG and IgA responses to Expanded Program on Immunization (EPI) vaccines and common childhood viral infections in 89 Ugandan infants. We integrated detailed parasitological surveillance and maternal clinical data to examine how P. falciparum infection history, concurrent parasitemia, maternal gravidity, and early-life viral exposures shaped serological profiles. We found that infants mounted robust responses to most EPI vaccines, but critical gaps in protection persisted for diphtheria, measles and rubella. Children born to primigravid mothers had lower antibody levels at 8 weeks of age, independent of placental malaria and only partially explained by maternal age. Contrary to expectation, cumulative P. falciparum exposure was positively associated with antibody concentrations to diphtheria and varicella, and concurrent parasitemia was positively correlated with responses to multiple antigens. Seroconversion to rhinovirus C was associated with higher IgG and IgA levels to several vaccines. Together, these findings suggest that common microbial exposures during infancy, including respiratory viruses and P. falciparum may positively modulate vaccine responsiveness.

PMID 42465441
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PubMedFrontiers in public health2026-07-17

A cross-sectional study of seroprevalence in Armenia, 2025: measles, mumps, rubella, and diphtheria.

Popova A Y AY, Smirnov V S VS, Egorova S A SA, Atoyan S A SA et al.

Prevention and control of vaccine-preventable infections is a key component of maintaining public health, and the overall state of immunity is the determining factor. To study herd immunity of the Armenian population to measles, rubella, mumps, and diphtheria. The study involved 5,513 individuals from all regions aged from 1 year and above. A cohort of volunteers, stratified into 9 age groups, was formed including by region and activity using a web application. For each infection, the presence and/or levels of immunoglobulin G were determined by the enzyme immunoassay method using Russian-made test systems. The cohort average seroprevalence values for measles, rubella, mumps, and diphtheria were 88.3%, 97.2, 83.2, and 56.3%, respectively. The least protected age groups were: children <5 years (80.7% seropositive) and adults 30-49 years (82-83%) regarding measles; adolescents and adults <49 years (73-79%) regarding mumps; and the older adults (34.4%) regarding diphtheria. Most volunteers had: low or moderate measles Ab levels (0.18-1 IU/mL); high levels of rubella Abs (>200 IU/mL); and a basic protective level of diphtheria toxin Abs (0.1-1 IU/mL). With age, a trend is seen: seropositivity for the viral pathogens (measles, mumps, and rubella) increased to maximum values; and diphtheria seropositivity decreased to minimum values. The level of herd immunity in Armenia is sufficient only for rubella, as confirmed by the absence of cases. Currently, immunity to measles and mumps is present, which prevents outbreaks but may not be fully preventive of sporadic cases. Despite the absence of diphtheria, insufficient protection in older adults makes them a risk group for incidence and severity. However, immunity levels in our study were assessed based only on humoral immunity, which may underrepresent the full immunological response, including that mediated by cellular immunity.

PMID 42465650
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PubMedThe Pan African medical journal2026-07-17

Factors associated with outbreak of diphtheria in Kafanchan, Kaduna State, Nigeria: July-October 2023.

Okhuarobo Uwaifiokun Julius UJ, Abbah Okpachi Christopher OC, Owoicho Samuel Amifofum SA, Okon Ubong Akpan UA et al.

The year 2023 witnessed the re-emergence of diphtheria in Nigeria. Kafanchan, Kaduna State, reported an unusual surge in cases and deaths. We investigated the outbreak to identify associated risk factors of the disease. We conducted an unmatched (1:2) case-control study. Case-patients were identified through the State linelist and traced to their residence. At the same time, controls were randomly selected from neighbors without symptoms or signs suggestive of diphtheria within the same community. Data was collected using an interviewer-administered structured questionnaire. Bivariate analysis was done to ascertain the odds ratio (OR), while multivariate logistic regression analysis was done to calculate the adjusted odds ratio (aOR). The confidence interval (CI) was set at 95%. A total of 91 case-patients and 182 controls were recruited. The median age of case-patients was 7 years (5-10 years). Forty (44%) of 91 case-patients were females. Sixty-four (70%) of 91 case-patients were from Kafanchan ward B, and the case fatality rate was 23%. Exposure to pentavalent vaccination was found to be associated with protection from diphtheria (aOR: 0.39, 95% CI: 0.20-0.77). Thirty-one (34.07%) of 91 case-patients had contact with someone with respiratory symptoms [OR = 37.2; 95% CI = 16.8-82.6; p <0.001]. Thirty-seven (40.66%) of 91 case-patients had contact with a confirmed case [OR = 25.1; 95% CI = 11.7-53.8; p < 0.001]. Twenty-three (25%) of 91 case-patients had never received the pentavalent vaccine, and the primary reason cited by caregivers was that they were unaware of any benefits of vaccination. The outbreak is attributable to suboptimal pentavalent vaccination coverage. Future outbreaks may be avoided or their impact reduced through improved risk communication and community engagement on the benefits of vaccination, strengthening routine immunization services, early warning surveillance, and prepositioning of diphtheria antitoxin (DAT) and antibiotics.

PMID 42465825
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PubMedbioRxiv : the preprint server for biology2026-07-17

Molecular-level analysis of serum IgG repertoires in COVID-19-vaccinated people with cystic fibrosis identifies abundant convergent antibodies.

Ionov Steven S, Connor Ruth I RI, Curtis Nicholas C NC, Shin Seungmin S et al.

People with cystic fibrosis (pwCF) are at increased risk of severe disease following respiratory viral infections including influenza and respiratory syncytial virus, and were therefore given priority for COVID-19 vaccination. Retrospective epidemiological data have revealed a lower incidence of SARS-CoV-2 infection and a reduced fatality rate among pwCF than in the general population, possibly from the stringent infection control measures and early adoption of protective behaviors. Despite several reports of adequate binding and neutralizing titers after vaccination, the molecular features of vaccine-elicited serum antibody repertoires in pwCF remain unknown. We performed high-resolution proteomic analysis of serum IgG, combined with next-generation sequencing of B cells, to quantitatively profile Spike (S)-reactive serological repertoires from nine infection-naïve pwCF after two doses of COVID-19 mRNA vaccine. We recombinantly expressed 20 IgG clonotypes from 6 pwCF as monoclonal antibodies (mAbs) and measured their binding and neutralization against vaccine-strain and variant viruses. All donors mounted strong binding and neutralizing titers to vaccine-strain virus. Ig-Seq revealed diverse serum repertoires in all vaccinees, with antibodies targeting the receptor-binding domain (RBD) comprising 64% of each circulating repertoire by abundance. Several serum IgG clonotypes identified across our cohort shared identical or similar IGHV and CDRH3 amino acid sequences with serum IgG from other pwCF or S-reactive mAbs isolated from non-CF individuals. These 'convergent' antibodies made up 14.6% of the anti-S repertoires in our cohort, reaching 24.8% in one pwCF. Convergent antibodies tended to be RBD-reactive and enriched in specific IGHV ; surprisingly, a higher abundance of convergent antibodies in serum correlated with a lower breadth of serum neutralization. All 20 mAbs bound Wuhan S with high affinity (EC 50 < 10 nM), and only RBD-reactive mAbs conferred neutralization to vaccine or variant pseudovirus. While most mAbs bound both the B.1.617.2 (Delta, 17/20) and B.1.1.529 (Omicron, 12/20) strains, convergent mAbs were less likely to bind either variant. Post-vaccine serum IgG repertoires in pwCF are dominated by RBD-focused, high-affinity antibodies and include a substantial convergent component shared with non-CF vaccinees. These findings demonstrate that pwCF mount antibody responses comparable to the general population, and a large group of convergent antibodies may contribute to strain-specific rather than cross-variant immunity.

PMID 42465256
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PubMedClinical infectious diseases : an official publication of the Infectious Diseases Society of America2026-07-17

Artificial Intelligence Across the Vaccine Clinical Trial Lifecycle: Evidence, Readiness, and Guardrails.

Idriss Jad J, Kalash Suha S, Faraj Jana Abu JA, Nolan Lauren L et al.

Artificial intelligence (AI) is increasingly being used to support clinical research, but its value in vaccine clinical trials requires careful evidence-based assessment. Vaccine trials pose distinctive challenges, including high safety expectations in healthy participants, evolving pathogen exposure and baseline immunity, incomplete correlates of protection, applicability of findings to intended-use populations, and intense public scrutiny. We conducted a structured, vaccine-focused narrative review of AI applications across the vaccine trial lifecycle, supplemented by targeted clinical trial and vaccine pharmacovigilance studies with directly transferable methods. In the combined evidence base, evidence is strongest for operational uses, particularly recruitment, eligibility screening, trial matching, and risk-based monitoring. Applications to immune-response interpretation, correlates of protection, and vaccine safety surveillance are promising but remain less prospectively validated. Responsible adoption should be guided by intended tool use, evidence of strength, data governance, regulatory expectations, and preservation of human scientific and safety judgment.

PMID 42464875
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