Immunogenicity and Safety of SARS-CoV-2 Protein Subunit Recombinant Vaccine (IndoVac®) as a Booster Dose against COVID-19 in Indonesian Adults.

According to the WHO target product profile for COVID-19 vaccines, the vaccine in development should be indicated for active immunisation in all populations. Therefore, PT Bio Farma developed a candidate vaccine in a subunit protein recombinant platform to help overcome the issue. This trial was an observer-blind, randomised, prospective intervention study. This study targeted individuals who had received complete primary doses of the authorised/approved COVID-19 vaccine. The groups were divided into the primary inactivated vaccine (CoronaVac®) group, the primary viral vector vaccine (ChAdOx1) group, and the primary mRNA vaccine (BNT162b2) group that received the recombinant protein (IndoVac®). The groups were compared with the control and primary mRNA vaccine (BNT162b2). The participants enrolled in the study were from two primary care centres in Bandung City and three primary care centres in Denpasar City. A total of 696 participants were enrolled from 1 September to 31 October 2022. The demographic characteristics of the all-vaccine group showed a uniform distribution. The results showed that, compared with the control, the investigational product had inferior effectiveness 14 days after the booster dose was administered. However, 28 days after the booster dose, the investigational product exhibited non-inferior effectiveness compared with the primary groups that received CoronaVac® (GMR 0.76 (0.57-0.99)) and ChAdOx1 (GMR 0.72 (0.56-59.93)), but the BNT162b2 group (GMR 0.61 (0.39-0.94)) was inferior to the control. At 12 months follow-up after the booster dose, three serious adverse events (SAEs) were reported in three participants, with causality not correlated with the investigated products. Neither AEs of special interest nor severe COVID-19 cases were reported throughout the follow-up period; thus, the IndoVac® vaccine as a booster was immunogenic and safe. Until the 6-month follow-up after the booster dose, the IndoVac® vaccine was well tolerated and all reported AEs resolved. This vaccine is registered and can be included in the immunisation programme.

Influence of mangrove forests on subjective and psychological wellbeing of coastal communities: Case studies in Malaysia and Indonesia.

Mangrove forests possess multiple functions for the environment and society through their valuable ecosystem services. Along with this, the mangrove forests have large and diverse social values, in combination contributing to the health and wellbeing of the surrounding communities. This study aims (i) to assess the benefits of mangrove forests and their impact on subjective and psychological wellbeing of coastal communities and (ii) to understand the challenges coastal communities face that limit sustainable wellbeing. We have used a mixed methodological approach, combining workshop, interview, and survey, to obtain qualitative and quantitative information from two coastal communities in Malaysia and Indonesia. For quantitative data, 67 participants from both coastal communities participated using a pre-tested structured questionnaire. To obtain opinions from key informants in Malaysia and Indonesia, we organized two stakeholders' workshops and community interviews. When merging these interviews and workshops, we identified the following three themes related to the perception of mangrove forest benefits: (1) the advantage of living in a natural countryside; (2) the natural resources supporting employment, income, and family security; and (3) the increase in subjective and psychological wellbeing. The mean score of wellbeing for Indonesian participants (28.6) was slightly higher than that for Malaysian participants (26.2) and was significant. Overall, the respondents felt happy because the combination of job security and leisure activities supports feeling content and satisfied. The analyses also suggest that the combination of exposure to coastal environments and stress reduction promotes good mental health; however, diagnostic health data are lacking. The lower score of mental wellbeing in Malaysia is attributed to respondents involved in risky fishing activities and local regions with excessive tourism. The findings from this study imply that coastal mangrove forest management plays an important role in the living conditions of coastal communities and their subjective and psychological wellbeing. Hence, restoration and sustainability of mangrove ecosystem are important.

The effect of cleaning and repainting on the ship drag penalty.

Although the hull of a recently dry-docked large ship is expected to be relatively smooth, surface scanning and experimentation reveal that it can exhibit an "orange-peel" roughness pattern with an equivalent sand-grain roughness height ks = 0. 101 mm. Using the known ks value and integral boundary layer evolution, a recently cleaned and coated full-scale ship was predicted to experience a significant increase in the average coefficient of friction %ΔC¯f and total hydrodynamic resistance %ΔR¯T during operation. Here the report also discusses two recently reported empirical estimations that can estimate ks directly from measured surface topographical parameters, by-passing the need for experiments on replicated surfaces. The empirical estimations are found to have an accuracy of 4.5 - 5 percentage points in %ΔC¯f.

Efficacy of Albendazole-Pyrantel Pamoate Compared to Albendazole Alone for Trichuris trichiura Infection in Children: A Double Blind Randomised Controlled Trial.

BACKGROUND: Soil transmitted helminths (STH) are intestinal nematodes and constitute one of the most neglected tropical diseases to exist. Objective: This study determined the efficacy of albendazole-pyrantel pamoate compared to albendazole in 8-12 years old children with Trichuris trichiura infection. METHODS: A randomised controlled trial was conducted between October 2017 and February 2018 on participants whose stool examinations confirmed the presence of Trichuris trichiura infection. The subjects were randomised into two groups. The statistical analysis used Chi-square test. RESULTS: There were 392 of 600 children at five public elementary schools in Bangli and Bali and were infected with Trichuris trichiura. The cure rate of Trichuris trichiura infection seven days following treatment was lower with the combination of albendazole and pyrantel pamoate compared to that of albendazole. The egg reduction rate of Trichuris trichiura infection was lower with the combination of albendazole and pyrantel pamoate compared to albendazole. CONCLUSION: The study indicated that a combination of albendazole and pyrantel pamoate does not improve cure rate or egg reduction rate in 8-12 years old children with Trichuris trichiura infection.

Underdiagnoses of Rickettsia in patients hospitalized with acute fever in Indonesia: observational study results.

BACKGROUND: Reports of human rickettsial infection in Indonesia are limited. This study sought to characterize the epidemiology of human rickettsioses amongst patients hospitalized with fever at 8 tertiary hospitals in Indonesia. METHODS: Acute and convalescent blood from 975 hospitalized non-dengue patients was tested for Rickettsia IgM and IgG by ELISA. Specimens from cases with seroconversion or increasing IgM and/or IgG titers were tested for Rickettsia IgM and IgG by IFA and Rickettsia genomes using primers for Rickettsia (R.) sp, R. typhi, and Orientia tsutsugamushi. Testing was performed retrospectively on stored specimens; results did not inform patient management. RESULTS: R. typhi, R. rickettsii, and O. tsutsugamushi IgG antibodies were identified in 269/872 (30.8%), 36/634 (5.7%), and 19/504 (3.8%) of samples, respectively. For the 103/975 (10.6%) non-dengue patients diagnosed with acute rickettsial infection, presenting symptoms included nausea (72%), headache (69%), vomiting (43%), lethargy (33%), anorexia (32%), arthralgia (30%), myalgia (28%), chills (28%), epigastric pain (28%), and rash (17%). No acute rickettsioses cases were suspected during hospitalization. Discharge diagnoses included typhoid fever (44), dengue fever (20), respiratory infections (7), leptospirosis (6), unknown fever (6), sepsis (5), hepatobiliary infections (3), UTI (3), and others (9). Fatalities occurred in 7 (6.8%) patients, mostly with co-morbidities. CONCLUSIONS: Rickettsial infections are consistently misdiagnosed, often as leptospirosis, dengue, or Salmonella typhi infection. Clinicians should include rickettsioses in their differential diagnosis of fever to guide empiric management; laboratories should support evaluation for rickettsial etiologies; and public policy should be implemented to reduce burden of disease.

Dengue viral infection in Indonesia: Epidemiology, diagnostic challenges, and mutations from an observational cohort study.

BACKGROUND: Dengue virus (DENV) infection is a major cause of acute febrile illness in Indonesia. Diagnostic inaccuracy may occur due to its varied and non-specific presentation. Characterization of DENV epidemiology, clinical presentation, and virology will facilitate appropriate clinical management and public health policy. METHODOLOGY/PRINCIPAL FINDINGS: A multicenter observational cohort study was conducted in Indonesia to assess causes of acute fever requiring hospitalization. Clinical information and specimens were collected at enrollment, 14-28 days, and 3 months from 1,486 children and adults. Total of 468 (31.9%) cases of DENV infection were confirmed by reference laboratory assays. Of these, 414 (88.5%) were accurately diagnosed and 54 had been misdiagnosed as another infection by sites. One hundred initially suspected dengue cases were finally classified as 'non-dengue'; other pathogens were identified in 58 of those cases. Mortality of DENV infection was low (0.6%). Prior DENV exposure was found in 92.3% of subjects >12 years. DENV circulated year-round in all cities, with higher incidence from January to March. DENV-3 and DENV-1 were the predominant serotypes. This study identified DENV-1 with TS119(C→T) substitution in the serotyping primer annealing site, leading to failure of serotype determination. CONCLUSIONS/SIGNIFICANCE: DENV is a common etiology of acute febrile illness requiring hospitalization in Indonesia. Diagnostic accuracy at clinical sites merits optimization since misdiagnosis of DENV infection and over-estimation of dengue can negatively impact management and outcomes. Mutation at the annealing site of the serotyping primer may confound diagnosis. Clinicians should consider following diagnostic algorithms that include DENV confirmatory testing. Policy-makers should prioritize development of laboratory capacity for diagnosis of DENV.

Complete metabolic remission of an irresectable mediastinal solitary fibrous tumour with concurrent chemoradiation.

Solitary fibrous tumour is a rare mesenchymal tumour of uncertain origin that occurs most frequently in the pleura, although it has also been described in extraserosal sites. The biological behaviour of the tumour is unpredictable. The case history is described of a patient diagnosed with a large symptomatic irresectable mediastinal solitary fibrous tumour who achieved a clinical, radiological and metabolic response after concurrent chemotherapy and radiotherapy.

In vitro efficacy of plant volatiles for inhibiting the growth of fruit and vegetable decay microorganisms.

The effects of acetaldehyde, benzaldehyde, cinnamaldehyde, ethanol, benzyl alcohol, nerolidol, 2-nonanone, beta-ionone, and ethyl formate vapors on the growth of Rhizopus stolonifer, Penicillium digitatum, Colletotrichum musae, Erwinia carotovora, and Pseudomonas aeruginosa on agar medium were evaluated. The aldehydes were found to be the strongest growth inhibitors and the most lethal to the fungal spores and mycelia and bacterial cells. The average minimum inhibitory concentrations (MICs) of aldehydes that were germicidal to decay microorganisms were 0.28, 0.49, and 0.88 mmol per Petri dish, for cinnamaldehyde, benzaldehyde, and acetaldehyde, respectively. Ethanol also inhibited growth completely, but the MIC, which was 14.6 mmol per Petri dish, was significantly higher than those of the aldehydes. Ethanol can be considered germistatic because the alcohol does not inhibit germination of spores completely; it completely controlled only mycelial growth. The ketones tended to be effective only on P. digitatum and C. musae, whereas ethyl formate was not effective except on P. digitatum. The concentration of a volatile compound in the headspace of the Petri dish and its diffusion into the medium largely determined its efficacy against decay microorganisms.

The role of hyaluronic acid capsular material of Streptococcus equi subsp. zooepidemicus in mediating adherence to HeLa cells and in resisting phagocytosis.

Hyaluronic acid is thought to be one of the critical virulence factors of Streptococcus equi subsp. zooepidemicus. The present study was designed to study the role of hyaluronic acid capsular material in mediating adherence and to resist the phagocytosis of the host's immune defence. The studies were performed with two encapsulated S. equi subsp. zooepidemicus and two unencapsulated phase variants. The bacteria had been previously isolated from diseased pigs and monkeys in Indonesia. The presence of capsular material was determined using the hyaluronic acid decapsulation test and by electron microscopic studies. Both encapsulated bacteria showed mucoid colonies after cultivation on blood agar, grew with diffuse colonies in soft agar media and reacted negatively in the salt aggregation test. The unencapsulated bacteria grew with small colonies on blood agar, formed compact colonies in soft agar media and reacted positively in the salt aggregation test. Adherence and phagocytosis studies revealed that the encapsulated bacteria adhered significantly more to HeLa cells and were less phagocytosed by murine macrophages compared to unencapsulated bacteria. Pretreatment of the HeLa cells using hyaluronic acid or pretreatment of the bacteria by hyaluronidase decreased the adherence value of encapsulated bacteria. Pretreatment of bacteria with pronase had no effect. The presented results strongly indicate that the hyaluronic acid capsular material contributes to adherence properties of S. equi subsp. zooepidemicus and might help the bacteria to resist phagocytosis by macrophages.

[Ascites, hydrothorax and ovarian tumor: Meigs' syndrome in a patient with small ovaries and increased CA 125 level]. / Ascites, hydrothorax en ovariumtumor: syndroom van Meigs, bij een patiënte met kleine ovaria en gestegen CA 125-waarde.

In a 51-year-old woman with bilateral Brenner tumours of the ovaries and with intermittent hydrothorax and ascites, Meigs' syndrome was diagnosed. The serum CA 125 level was 620 U/ml (normal: 5-35). Bilateral ovariectomy, hysterectomy and omentectomy were carried out. The ovaries were not enlarged. Postoperatively, the pleural effusion and ascites resolved and the CA 125 level decreased to 8.4 U/ml. The pathogenesis of hydrothorax probably involves passage through the diaphragm, and the CA 125 may be produced by the peritoneal lining or by the Brenner tumours.

A comparison of fluticasone propionate, 1 mg daily, with beclomethasone dipropionate, 2 mg daily, in the treatment of severe asthma. International Study Group.

We wanted to compare the efficacy and safety of fluticasone propionate, a new topically active inhaled corticosteroid, to that of high dose beclomethasone dipropionate, in severe adult asthma. Patients currently receiving between 1.5-2.0 mg.day-1 of an inhaled corticosteroid were treated for six weeks in a double-blind, randomized, parallel group study with 1 mg.day-1 fluticasone propionate (n = 82), or 2 mg.day-1 beclomethasone dipropionate (n = 72). Mean morning peak expiratory flow rates (PEFR) increased from 303 to 321 l.min-1 with fluticasone propionate, and from 294 to 319 l.min-1 with beclomethasone dipropionate. There was an increase in evening PEFR, asthma symptoms improved, and rescue beta 2-agonist use decreased for both treatment groups. None of these differences between treatments were statistically significant. However, diurnal variation was significantly reduced with fluticasone propionate, when compared with beclomethasone dipropionate (difference = 7 l.min-1; p = 0.038). Clinic lung function also improved with both treatments and, apart from % predicted PEFR, which showed no difference after beclomethasone dipropionate but increased from 73 to 78% with fluticasone propionate, there were no differences between treatments. Forced expiratory volume in one second (FEV1) increased with both treatments. The geometric mean plasma cortisol concentration rose after treatment with fluticasone propionate (from 293 to 309 nmol.l-1) and fell after beclomethasone dipropionate (from 256 to 224 nmol.l-1); the difference between treatments was significant. The incidence of adverse events was low in both treatment groups. In conclusion, 1 mg.day-1 fluticasone propionate was as effective as 2 mg.day-1 beclomethasone dipropionate in the control of severe asthma.(ABSTRACT TRUNCATED AT 250 WORDS)

Phase II study of high-dose epirubicin in non-small cell lung cancer.

24 patients with measurable advanced non-small cell lung cancer (NSCLC) were treated with epirubicin 135-150 mg/m2 every 3 weeks. There were 6 partial responses. Randomised studies should reveal whether and how incorporation of epirubicin into combination chemotherapy can enhance outcome in advanced NSCLC.

Chemotherapy consisting of epirubicin, cisplatin, and etoposide followed by irradiation in stage III non-small cell lung cancer and chemotherapy alone in stage IV non-small cell lung cancer.

Twenty-eight patients with stage III non-small cell lung cancer were treated with the sequential administration of combination chemotherapy consisting of epirubicin, cisplatin, and etoposide and of irradiation. The response rate was 57% including 15% complete responses. The median survival time was 11 months. Eighteen patients with stage IV disease received the same chemotherapy. The response rate was 55% including 11% complete responses, but the median survival time was only 5 months. It is concluded that this protocol is as active as the combination of doxorubicin, etoposide, and cisplatin, but probably less toxic.

Chemotherapy preceding radiotherapy in stage III non-small cell lung cancer.

Thirty-seven patients with stage III non-small cell lung cancer were treated with the sequential administration of chemotherapy, consisting of Cisplatinum, VP-16 and Adriamycin, and radiotherapy. The response rate in 33 evaluable patients was 82 percent. The median survival for all evaluable patients was 11 months; 5 patients actually survived more than 24 months but all ultimately relapsed. It is concluded that treatment of advanced non-small cell lung cancer with the currently available tools is still unsatisfactory. Despite a high response rate our treatment protocol had only a modest impact on survival. Obviously, a concerted effort will be required to improve these results and will probably involve the development of new and better drugs.

Phase II randomized trial of radiotherapy alone vs the sequential use of chemotherapy and radiotherapy in stage III non-small cell lung cancer. Phase II trial of chemotherapy alone in stage IV non-small cell lung cancer.

In order to clarify if the sequential combination of chemotherapy and radiotherapy offered any advantage over radiotherapy alone in stage III non-small cell lung cancer, 33 patients were randomized between radiotherapy alone or chemotherapy followed by radiotherapy, then chemotherapy again. Chemotherapy consisted of a combination of cisplatinum, VP-16 and adriamycin. Twenty-four patients with stage IV disease received the same chemotherapy regimen alone for six cycles. Median survival for stage III patients receiving radiotherapy alone was 5 months. For patients receiving the sequential combination of chemotherapy and radiotherapy median survival was 11 months (log-rank test, P = 0.025). Median survival for stage IV patient receiving chemotherapy alone was 15 months. It is concluded that the sequential combination of chemotherapy and radiotherapy is significantly superior to radiotherapy alone in patients with stage III non-small cell lung cancer.

Pharmacokinetics and pharmacodynamics of a short- and long-acting theophylline medication (theolair and Theolair retard) in normals and asthmatics. Part I: pharmacokinetics.

Plasma concentration and pharmacokinetic data of a sustained-release theophylline (Theolair retard) was compared with that of a short-acting theophylline (Theolair) in six normals and six patients with asthmatic bronchitis. Steady-state plasma levels were reached on day 4 or earlier for both Theolair retard and Theolair. Theolair retard showed stable plasma concentrations. Patients showed lower (maximal) values for the plasma levels for Theolair retard and for Theolair and a shorter elimination half-life time for Theolair. This may perhaps be explained by the larger number of smokers among the patients versus the normals. As for the large interindividual variation in plasma levels and pharmacokinetics it seems advisable to administer theophylline guided by plasma levels estimated on the 4th day of administration, about 3 h after the morning dose.

Pharmacokinetics and pharmacodynamics of a short- and long-acting theophylline medication (Theolair and Theolair retard) in normals and asthmatics. Part II: Lung function and side effects.

Six normals and six patients with chronic obstructive lung disease were treated with a short- and long-acting theophylline (Theolair and Theolair retard). During treatment the lung function data of the patients showed an improvement on day 1, but no further improvement on days 4 and 7, despite the higher theophylline plasma concentration on these last days. There was no close correlation between the improvement of lung function and the theophylline plasma concentration, nor was there any difference between Theolair and Theolair retard as regards improvement of lung function. Side effects were negligible, and the theophylline plasma concentration was rather low. It seems advisable to use a higher dosage of the theophyllines and perhaps it is even better to combine them with other bronchodilators.

Pharmacokinetics and pharmacodynamics of a short- and long-acting theophylline medication (Theolair and Theolair retard) in normals and patients with COLD. Part III: Plasma cyclic AMP.

Supporting evidence was found for the beta-blockade theory of Szentivanyi. Asthmatics (n = 6) showed lower basal plasma cyclic AMP levels and lower cyclic AMP levels after administration of a short- and long-acting theophylline preparations (Theolair and Theolair retard) than normals (n = 6) did. No difference was found in this respect between Theolair and Theolair retard. Basal cyclic AMP levels showed a diurnal variation, with highest levels in the morning which gradually decreased during the day. The correlation of the plasma cyclic AMP levels with the lung function change after stimulation with theophyllines in asthmatics was rather poor. This is probably caused by the rather low changes in plasma cyclic AMP levels.